Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05715905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analyzing Clinical Trial Experiences of Colon Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-27', 'size': 75653, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-01-27T06:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of colon cancer patients who decide to enroll in a clinical trial', 'timeFrame': '3 months'}, {'measure': 'Rate of patients who remain in a colon cancer clinical trial to trial completion', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colon Cancer', 'Colon Disease'], 'conditions': ['Colon Cancer', 'Colon Disease']}, 'referencesModule': {'references': [{'pmid': '20138539', 'type': 'BACKGROUND', 'citation': 'Labianca R, Beretta GD, Kildani B, Milesi L, Merlin F, Mosconi S, Pessi MA, Prochilo T, Quadri A, Gatta G, de Braud F, Wils J. Colon cancer. Crit Rev Oncol Hematol. 2010 May;74(2):106-33. doi: 10.1016/j.critrevonc.2010.01.010.'}, {'pmid': '29496094', 'type': 'BACKGROUND', 'citation': 'Mody K, Bekaii-Saab T. Clinical Trials and Progress in Metastatic Colon Cancer. Surg Oncol Clin N Am. 2018 Apr;27(2):349-365. doi: 10.1016/j.soc.2017.11.008.'}, {'pmid': '28923225', 'type': 'BACKGROUND', 'citation': 'Iqbal A, George TJ. Randomized Clinical Trials in Colon and Rectal Cancer. Surg Oncol Clin N Am. 2017 Oct;26(4):689-704. doi: 10.1016/j.soc.2017.05.008. Epub 2017 Aug 18.'}]}, 'descriptionModule': {'briefSummary': "Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.\n\nThis trial will admit a wide range of data on the clinical trial experience of Colon Cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.\n\nIt will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Colon Cancer patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Colon cancer patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been diagnosed with colon cancer\n* Patient has self-identified as planning to enroll in an observational clinical trial\n* Patient is a minimum of 18 years or older\n\nExclusion Criteria:\n\n* Pregnant or nursing patients\n* Inability to perform regular electronic reporting\n* Patient does not understand, sign, and return consent form'}, 'identificationModule': {'nctId': 'NCT05715905', 'briefTitle': 'Analyzing Clinical Trial Experiences of Colon Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'An In Depth Study Evaluating Patterns in the Colon Cancer Patients Clinical Trials', 'orgStudyIdInfo': {'id': '81122503'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '4159004227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}