Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-25 @ 4:15 AM
Study NCT ID:
NCT02394769
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2015-03-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ASPirin Intervention for the REDuction of Colorectal Cancer Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'achan@partners.org', 'phone': '(617) 726-3212', 'title': 'Andrew T. Chan, MD, MPH', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (For Aspirin)', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.\n\nPlacebo for Aspirin', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 14, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.\n\nAspirin', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 17, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Standard Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.\n\nAspirin', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 17, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GI upset (i.e. heartburn/acid reflux/nausea/gas)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Unrelated infection/cold symptoms/sinus related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Extended bleeding/bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bleeding hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Seasonal allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Other, unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urinary Prostaglandin Metabolites (PGE-M)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (For Aspirin)', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.\n\nPlacebo for Aspirin'}, {'id': 'OG001', 'title': 'Low Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.\n\nAspirin'}, {'id': 'OG002', 'title': 'Standard Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.\n\nAspirin'}], 'classes': [{'title': 'Baseline urinary PGE-M', 'categories': [{'measurements': [{'value': '15.5', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '17.1', 'groupId': 'OG001'}, {'value': '14.3', 'spread': '13.7', 'groupId': 'OG002'}]}]}, {'title': 'Post-intervention urinary PGE-M', 'categories': [{'measurements': [{'value': '16.4', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '7.9', 'groupId': 'OG002'}]}]}, {'title': 'Change in urinary PGE-M', 'categories': [{'measurements': [{'value': '0.8', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '17.7', 'groupId': 'OG001'}, {'value': '-4.9', 'spread': '11.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8-12 weeks', 'description': 'Measured using liquid chromatography/mass spectrometry', 'unitOfMeasure': 'ng/mg cr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Macrophage Inhibitory Cytokine-1 (MIC-1), an Inflammatory Biomarker', 'timeFrame': '8-12 weeks', 'description': 'Measured using an ELISA for MIC-1', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Chromatin Binding', 'timeFrame': '8-12 weeks', 'description': 'Measured using ChIP-Seq of DNA extracted from colonic epithelium', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Expression of Wnt-associated Signaling Genes (CTNNB1, AXIN2 and MYC)', 'timeFrame': '8-12 weeks', 'description': 'Measured using RNA-seq of colonic epithelium', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Spectral Biomarkers of Colorectal Cancer', 'timeFrame': '8-12 weeks', 'description': 'Measured using Partial Wave Spectroscopy on rectal cytology brushing samples', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (For Aspirin)', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.\n\nPlacebo for Aspirin'}, {'id': 'FG001', 'title': 'Low Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.\n\nAspirin'}, {'id': 'FG002', 'title': 'Standard Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.\n\nAspirin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Patients who meet the inclusion criteria will be identified through investigators during their routine clinical practice, supplemented by a periodic query of the MGH endoscopy and pathology databases. Potentially eligible participants are approached by letter from their treating physician. Two weeks after receiving the letter, study staff will contact eligible parties and screen for eligibility via phone interview. Enrollment began in July 2015 and ended in February 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (For Aspirin)', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.\n\nPlacebo for Aspirin'}, {'id': 'BG001', 'title': 'Low Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.\n\nAspirin'}, {'id': 'BG002', 'title': 'Standard Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.\n\nAspirin'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '57.1', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '8.3', 'groupId': 'BG002'}, {'value': '56.9', 'spread': '8.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Married', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}, {'title': 'Never married', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Separated', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Divorced', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Widowed', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '26.8', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '28.4', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '27.5', 'spread': '5.7', 'groupId': 'BG002'}, {'value': '27.6', 'spread': '5.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index, categories', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Normal, <18.5-24.9', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}, {'title': 'Overweight, 25.0-29.9', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}, {'title': 'Obese ≥30.0', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}, {'title': 'Former', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Current', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol consumption', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Rarely', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': '1-5 times/week', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Daily', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'More than daily', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Personal cancer history, yes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Family history of colorectal cancer, yes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type II diabetes, yes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Menopause status', 'classes': [{'title': 'Premenopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Perimenopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Postmenopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Menopausal status of female participants, only'}, {'title': 'History of 81 mg aspirin use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}, {'title': 'Intermittently (<2x/week)', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Regularly (>2x/week)', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of 325 mg aspirin use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'Intermittently (<2x/week)', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Regularly (>2x/week)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of non-steroidal anti-inflammatory drug use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}, {'title': 'Intermittently (<2x/week)', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}, {'title': 'Regularly (>2x/week)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Proton pump inhibitor use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Current and regular', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'No, never regularly', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'H2-blocker use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Current and regular', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'No, never regularly', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Antacid use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Current and regular', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'No, never regularly', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Statin use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Current and regular', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'No, never regularly', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-14', 'size': 1233263, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-28T12:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2015-03-16', 'resultsFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-02-28', 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urinary Prostaglandin Metabolites (PGE-M)', 'timeFrame': '8-12 weeks', 'description': 'Measured using liquid chromatography/mass spectrometry'}], 'secondaryOutcomes': [{'measure': 'Plasma Macrophage Inhibitory Cytokine-1 (MIC-1), an Inflammatory Biomarker', 'timeFrame': '8-12 weeks', 'description': 'Measured using an ELISA for MIC-1'}, {'measure': 'Chromatin Binding', 'timeFrame': '8-12 weeks', 'description': 'Measured using ChIP-Seq of DNA extracted from colonic epithelium'}, {'measure': 'Expression of Wnt-associated Signaling Genes (CTNNB1, AXIN2 and MYC)', 'timeFrame': '8-12 weeks', 'description': 'Measured using RNA-seq of colonic epithelium'}, {'measure': 'Spectral Biomarkers of Colorectal Cancer', 'timeFrame': '8-12 weeks', 'description': 'Measured using Partial Wave Spectroscopy on rectal cytology brushing samples'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '28143522', 'type': 'BACKGROUND', 'citation': 'Drew DA, Chin SM, Gilpin KK, Parziale M, Pond E, Schuck MM, Stewart K, Flagg M, Rawlings CA, Backman V, Carolan PJ, Chung DC, Colizzo FP 3rd, Freedman M, Gala M, Garber JJ, Huttenhower C, Kedrin D, Khalili H, Kwon DS, Markowitz SD, Milne GL, Nishioka NS, Richter JM, Roy HK, Staller K, Wang M, Chan AT. ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED): a study protocol for a randomized controlled trial. Trials. 2017 Feb 1;18(1):50. doi: 10.1186/s13063-016-1744-z.'}, {'pmid': '32718943', 'type': 'BACKGROUND', 'citation': 'Drew DA, Schuck MM, Magicheva-Gupta MV, Stewart KO, Gilpin KK, Miller P, Parziale MP, Pond EN, Takacsi-Nagy O, Zerjav DC, Chin SM, Mackinnon Krems J, Meixell D, Joshi AD, Ma W, Colizzo FP, Carolan PJ, Nishioka NS, Staller K, Richter JM, Khalili H, Gala MK, Garber JJ, Chung DC, Yarze JC, Zukerberg L, Petrucci G, Rocca B, Patrono C, Milne GL, Wang M, Chan AT. Effect of Low-dose and Standard-dose Aspirin on PGE2 Biosynthesis Among Individuals with Colorectal Adenomas: A Randomized Clinical Trial. Cancer Prev Res (Phila). 2020 Oct;13(10):877-888. doi: 10.1158/1940-6207.CAPR-20-0216. Epub 2020 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'This research study is investigating the use of aspirin as a potential chemopreventive agent to reduce risk of colorectal cancer', 'detailedDescription': 'This research study, is investigating the use of aspirin as a potential chemopreventive agent to reduce risk of colorectal cancer. Within the gastroenterology practice of Massachusetts General Hospital (MGH), we will conduct a prospective, double-blind, placebo-controlled, randomized clinical trial to measure the effects of daily low-dose (81 mg/day) and standard-dose (325 mg/day) aspirin on urine, plasma, stool, and tissue biomarkers associated with colorectal cancer.\n\nAspirin is part of the non-steroidal anti-inflammatory drug (NSAID) family, which are drugs routinely used for their pain-killing (analgesic), fever-reducing (antipyretic), or anti-inflammatory properties. Most NSAIDs are available as over-the-counter formulations. Substantial evidence has conclusively demonstrated that aspirin reduces the risk of colorectal neoplasia, yet there remains uncertainty surrounding its mode of action. Aspirin has already been established to reduce the risk of cardiovascular disease. Prospective studies as well as randomized clinical trials demonstrate that aspirin reduces the risk of precancerous polyps and colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Underwent screening or surveillance colonoscopy at MGH within the last 9 months with removal of at least one adenoma.\n* Age 18-80 years.\n* This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults. Patients over age 80 will not be enrolled since the benefits and risks of a daily aspirin regimen over the age of 80 have not yet been well-characterized.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Not currently taking aspirin (any dose) within the last 6 months.\n* The effects of aspirin on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Use of any non-aspirin non-steroidal anti-inflammatory drug (NSAID) at any dose at least three times a week during the two months prior to randomization.\n* Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis\n* Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of non- melanoma skin) in which there has been any active treatment within the last three years\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to aspirin.\n* Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).\n* Any adenoma that was not completely removed during previous colonoscopy.\n* History of aspirin intolerance, bleeding diathesis, peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy.\n* Inability or unwillingness to abstain from non-protocol use of aspirin or NSAIDs or to provide blood, urine, or stool samples or colon biopsies during the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding.\n* Pregnant women are excluded from this study because aspirin is an FDA Category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with aspirin, breastfeeding should be discontinued if the mother is treated with aspirin.\n* Participant must be able to swallow pills.\n* Participant is taking any anticoagulant agent (e.g. warfarin) or antiplatelet agent (e.g. clopidogrel).'}, 'identificationModule': {'nctId': 'NCT02394769', 'acronym': 'ASPIRED', 'briefTitle': 'ASPirin Intervention for the REDuction of Colorectal Cancer Risk', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'ASPIRED: ASPirin Intervention for the REDuction of Colorectal Cancer Risk', 'orgStudyIdInfo': {'id': '14-496'}, 'secondaryIdInfos': [{'id': 'R01CA137178', 'link': 'https://reporter.nih.gov/quickSearch/R01CA137178', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (For Aspirin)', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.', 'interventionNames': ['Drug: Placebo for Aspirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.', 'interventionNames': ['Drug: Aspirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Dose Aspirin', 'description': 'The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.', 'interventionNames': ['Drug: Aspirin']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['2-Acetylsalicylic Acid', 'ASA'], 'armGroupLabels': ['Low Dose Aspirin', 'Standard Dose Aspirin']}, {'name': 'Placebo for Aspirin', 'type': 'DRUG', 'armGroupLabels': ['Placebo (For Aspirin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Andrew T Chan, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrew T. Chan, MD, MPH', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}