Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-28 @ 3:11 AM
Study NCT ID:
NCT04723095
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2020-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081204', 'term': 'Chromatin Immunoprecipitation Sequencing'}, {'id': 'D005500', 'term': 'Follow-Up Studies'}], 'ancestors': [{'id': 'D047369', 'term': 'Chromatin Immunoprecipitation'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D059014', 'term': 'High-Throughput Nucleotide Sequencing'}, {'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D017422', 'term': 'Sequence Analysis, DNA'}, {'id': 'D047468', 'term': 'Immunoprecipitation'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2044-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2044-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease characterization data', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Information collected from retrospective and prospective review of medical records.'}, {'measure': 'Patient treatment data', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Information collected from retrospective and prospective review of medical records.'}, {'measure': 'Patient outcome data', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Information collected from retrospective and prospective review of medical records.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Large Cell Neuroendocrine Carcinoma', 'Cervical Neuroendocrine Carcinoma', 'Cervical Small Cell Carcinoma', 'Cervical Undifferentiated Carcinoma', 'Stage I Cervical Cancer AJCC v8', 'Stage IA Cervical Cancer AJCC v8', 'Stage IA1 Cervical Cancer AJCC v8', 'Stage IA2 Cervical Cancer AJCC v8', 'Stage IB Cervical Cancer AJCC v8', 'Stage IB1 Cervical Cancer AJCC v8', 'Stage IB2 Cervical Cancer AJCC v8', 'Stage II Cervical Cancer AJCC v8', 'Stage IIA Cervical Cancer AJCC v8', 'Stage IIA1 Cervical Cancer AJCC v8', 'Stage IIA2 Cervical Cancer AJCC v8', 'Stage IIB Cervical Cancer AJCC v8', 'Stage III Cervical Cancer AJCC v8', 'Stage IIIA Cervical Cancer AJCC v8', 'Stage IIIB Cervical Cancer AJCC v8', 'Stage IV Cervical Cancer AJCC v8', 'Stage IVA Cervical Cancer AJCC v8', 'Stage IVB Cervical Cancer AJCC v8']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This study collects information and data on patients with neuroendocrine cervical cancer. Information from this study may be used to better understand the correlation between clinical data, such as patient characteristics, treatment, and disease outcomes, and overall patient outcomes.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for patients with neuroendocrine carcinoma of the uterine cervix.\n\nII. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.\n\nIII. To have a single data repository kept on a secure platform that will integrate clinical information and research findings and serve as an archive for future research.\n\nOUTLINE:\n\nPatients' medical records are reviewed retrospectively and prospectively. All prospective patients will be contacted via email, telephone, or U.S. Mail on case by case basis for up to 10 years to check status of disease and any further treatment received. Project staff can also access the patient's M. D. Anderson Epic medical record for updates. Request for additional clinic and treatment notes will be submitted to external medical institutions listed in the physician information form in order to access updated notes for non- M. D. Anderson patients"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with neuroendocrine cervical cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a personal history of cervical cancer with any portion of neuroendocrine component (including mixed tumors) of the following histologic subtypes:\n\n * Small cell neuroendocrine carcinoma\n * Large cell neuroendocrine carcinoma\n * Undifferentiated high-grade neuroendocrine carcinoma\n* Patients may be in any stage of treatment, surveillance or recurrence at the time of initial participation in the study\n* Patients with all stages of disease are considered eligible\n* Patients who do not speak English can be eligible if accompanied by an institutional interpreter\n* Patients who are receiving or have received treatment at any facility, including but not limited to M. D. Anderson Cancer Center are eligible\n* Patient may be residents of any country and be of any ethnic background\n* Patients who request to participate in the study, regardless of the method by which they learned of it, are eligible to participate, including, but not limited to patients who seek participation via the website\n* Next of kin or legal authorized representatives of patients who are deceased but had a history of neuroendocrine carcinoma (NEC) of the cervix are eligible to participate\n* Next of kin or legal authorized representatives of patients must read and speak English\n\nExclusion Criteria:\n\n* Patients with other histologic subtypes of NEC of the cervix including typical and atypical carcinoid tumors'}, 'identificationModule': {'nctId': 'NCT04723095', 'acronym': 'NeCTuR', 'briefTitle': 'Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix', 'orgStudyIdInfo': {'id': 'PA12-1006'}, 'secondaryIdInfos': [{'id': 'NCI-2020-07408', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'PA12-1006', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (medical chart review)', 'description': "Patients' medical records are reviewed retrospectively and prospectively. All prospective patients will be contacted via email, telephone, or U.S. Mail on case by case basis for up to 10 years to check status of disease and any further treatment received. Project staff can also access the patient's M. D. Anderson Epic medical record for updates. Request for additional clinic and treatment notes will be submitted to external medical institutions listed in the physician information form in order to access updated notes for non- M. D. Anderson patients.", 'interventionNames': ['Other: Follow-Up', 'Other: Medical Chart Review']}], 'interventions': [{'name': 'Follow-Up', 'type': 'OTHER', 'otherNames': ['Active Follow-up', 'Clinical Signs Follow-up', 'CLSFUP', 'Follow Up', 'Followed', 'Followup'], 'description': 'Receive follow up', 'armGroupLabels': ['Observational (medical chart review)']}, {'name': 'Medical Chart Review', 'type': 'OTHER', 'otherNames': ['Chart Review'], 'description': 'Review of medical records', 'armGroupLabels': ['Observational (medical chart review)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Larissa A. Meyer, MD', 'role': 'CONTACT', 'email': 'lmeyer@mdanderson.org', 'phone': '713-745-0973'}, {'name': 'Larissa A. Meyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Larissa A. Meyer, MD', 'role': 'CONTACT', 'email': 'lmeyer@mdanderson.org', 'phone': '713-745-0973'}], 'overallOfficials': [{'name': 'Larissa A. Meyer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}