Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-04-22 @ 10:00 AM
Study NCT ID:
NCT05831150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-26
First Post:
2023-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discovering Patterns in Experiences of Patients in Esophageal Cancer Clinical Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-13', 'size': 67431, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-14T02:14', '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': '2024-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who decide to enroll in a clinical research.', 'timeFrame': '3 months'}, {'measure': 'Number of study participants who remain in clinical research until completion.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal cancer'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '11928803', 'type': 'BACKGROUND', 'citation': 'Kim HJ, Bains MS. Randomized clinical trials in esophageal cancer. Surg Oncol Clin N Am. 2002 Jan;11(1):89-109, viii. doi: 10.1016/s1055-3207(03)00076-0.'}, {'pmid': '33042518', 'type': 'BACKGROUND', 'citation': 'Harada K, Rogers JE, Iwatsuki M, Yamashita K, Baba H, Ajani JA. Recent advances in treating oesophageal cancer. F1000Res. 2020 Oct 1;9:F1000 Faculty Rev-1189. doi: 10.12688/f1000research.22926.1. eCollection 2020.'}, {'pmid': '32067548', 'type': 'BACKGROUND', 'citation': 'Zhou N, Hofstetter WL. Prognostic and therapeutic molecular markers in the clinical management of esophageal cancer. Expert Rev Mol Diagn. 2020 Apr;20(4):401-411. doi: 10.1080/14737159.2020.1731307. Epub 2020 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups.\n\nThis study will investigate the safety and efficacy of esophageal cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals.\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 esophageal cancer research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are actively considering involvement in an observational esophageal cancer clinical trial, but have not yet completed enrollment and registration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years of age\n* Diagnosis of esophageal cancer\n* Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n* Women of childbearing potential without a negative pregnancy test; or women who are lactating.\n* Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.\n* Inability to perform regular electronic reporting'}, 'identificationModule': {'nctId': 'NCT05831150', 'briefTitle': 'Discovering Patterns in Experiences of Patients in Esophageal Cancer Clinical Research', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Investigating Factors Affecting Clinical Trial Participation Rates in Patients With Esophageal Cancer', 'orgStudyIdInfo': {'id': '82828643'}}, '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'}}}}