Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT05789628
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-29
First Post:
2023-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Discovering Factors in Cervical Cancer Patients' Clinical Trial Experiences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-16', 'size': 77854, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-16T09:32', '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': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who decide to enroll in a cervical cancer clinical study.', 'timeFrame': '3 months'}, {'measure': 'Number of cervical cancer study participants who remain in clinical trial until completion.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical Cancer'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '30629194', 'type': 'BACKGROUND', 'citation': 'Hu L, Bell D, Antani S, Xue Z, Yu K, Horning MP, Gachuhi N, Wilson B, Jaiswal MS, Befano B, Long LR, Herrero R, Einstein MH, Burk RD, Demarco M, Gage JC, Rodriguez AC, Wentzensen N, Schiffman M. An Observational Study of Deep Learning and Automated Evaluation of Cervical Images for Cancer Screening. J Natl Cancer Inst. 2019 Sep 1;111(9):923-932. doi: 10.1093/jnci/djy225.'}, {'pmid': '23706117', 'type': 'BACKGROUND', 'citation': 'Peirson L, Fitzpatrick-Lewis D, Ciliska D, Warren R. Screening for cervical cancer: a systematic review and meta-analysis. Syst Rev. 2013 May 24;2:35. doi: 10.1186/2046-4053-2-35.'}, {'pmid': '29693331', 'type': 'BACKGROUND', 'citation': 'Saei Ghare Naz M, Kariman N, Ebadi A, Ozgoli G, Ghasemi V, Rashidi Fakari F. Educational Interventions for Cervical Cancer Screening Behavior of Women: A Systematic Review. Asian Pac J Cancer Prev. 2018 Apr 25;19(4):875-884. doi: 10.22034/APJCP.2018.19.4.875.'}]}, 'descriptionModule': {'briefSummary': "The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.\n\nThis research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for cervical cancer.\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 cervical cancer studies."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are actively considering involvement in an observational cervical cancer clinical trial, but have not yet completed enrollment and registration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Ability to understand and the willingness to sign a written informed consent document.\n* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\n\nExclusion Criteria:\n\n* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial\n* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.'}, 'identificationModule': {'nctId': 'NCT05789628', 'briefTitle': "Discovering Factors in Cervical Cancer Patients' Clinical Trial Experiences", 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'A Look at the Patterns in Medical Research Participation Among Patients With Cervical Cancer', 'orgStudyIdInfo': {'id': '85789149'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '415-900-4227'}], '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'}}}}