Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT03771651
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2018-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital 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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects who exhibited alterations in the fallopian tube immune microenvironment', 'timeFrame': '5 years', 'description': 'Immuno-cellular assays and percentages of specific immune cells will be compared to control tissue samples.'}, {'measure': 'Number of subjects who exhibited less carcinogenic potential than control specimens', 'timeFrame': '5 years', 'description': 'Ciliate cells from specimens will be isolated and the number of colony forming units will be compared to control samples.'}, {'measure': 'Number of subjects who exhibited changes in transcriptome profile compared to control specimens', 'timeFrame': '5 years', 'description': 'Normal fallopian tube fibria will be compared to ovarian cancer specimens to identify novel biomarkers for diagnosis, targets for prevention and better treatment strategies.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fallopian Tube Cancer', 'Fallopian Tube Infection']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the impact of low dose aspirin on normal fallopian tube fimbriae in women who have surgery to have their fallopian tubes removed. Participants will take a low dose of aspirin for 2 weeks before their surgery. A portion of the removed fallopian tubes will also be collected for future research and routine pathology purposes.', 'detailedDescription': "Subjects in this study will receive low dose aspirin for 14 days before undergoing surgery to remove fallopian tubes removed to determine whether aspirin decreases inflammation in the fallopian tube. Subjects will also submit blood samples at their initial visit with their oncologist, at the time of surgery and at the pre-operative visit to measure inflammation markers and blood counts. A portion of the subject's fallopian tube will be collected for future research studies."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing gynecologic surgery for presumed benign indications that includes the removal of their fallopian tubes. This may include sterilization procedures, hysterectomy or partial or full adnexectomy.\n* Eligible women will have fulfilled their childbearing desires\n* Age \\> 21 Considered low risk for prevalent fallopian tube cancer (not undergoing risk reducing surgery for a known BRCA mutation or other known hereditary predisposition syndrome, family history of ovarian cancer in a first degree relative.\n\nExclusion Criteria:\n\n* Males\n* Women who have presumed or known gynecologic cancer\n* Women less than 21 years of age\n* Women currently on either regular aspirin therapy, non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen or chronic steroidal anti-inflammatory medications.\n* Women with known bleeding diathesis or bleeding disorder.\n* Women who do not consent for removal of both fallopian tubes.\n* Women with a history of gastritis or peptic ulcer disease requiring treatment. (Patients with a history of occasional H1 or H2 blocker use for gastro esophageal reflux disease are NOT excluded).\n* Women with reported aspirin or NSAID allergy\n* Women with asthma and/or nasal polyps'}, 'identificationModule': {'nctId': 'NCT03771651', 'briefTitle': 'Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'A Surgical Window Pilot Investigation of Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube', 'orgStudyIdInfo': {'id': '9955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspirin', 'description': 'Subjects will take 81mg tablets of aspirin daily for 14 days prior to surgery for removal of fallopian tubes.', 'interventionNames': ['Drug: Aspirin 81 mg']}], 'interventions': [{'name': 'Aspirin 81 mg', 'type': 'DRUG', 'description': 'Subjects will take aspirin daily for 14 days leading up to surgery to determine whether it impacts inflammation of fallopian tubes.', 'armGroupLabels': ['Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73117', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Stephenson Cancer Center, University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Laura Holman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stephenson Cancer Center, University of Oklahoma Health Sciences Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}