Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 5:49 PM
Study NCT ID:
NCT07179757
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To report patterns of relapse in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy)', 'timeFrame': '5 years', 'description': 'To Report pattern of relapse in patients measure by Clinical Examination , By taking folllow up and Symptoms Reporting'}, {'measure': 'To report patterns of disease outcome in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy)', 'timeFrame': '5 Years', 'description': 'To Report pattern of relapse in patients measure by Clinical Examination , By taking folllow up and Symptoms Reporting'}], 'secondaryOutcomes': [{'measure': 'To report outcomes as a function of p16, AKT, PDL-1 expression.', 'timeFrame': '5 years', 'description': 'IHC Staining will be performed for p16, AKT, PDL-1 expression'}, {'measure': 'To report on acute and late effect of treatment outcomes using CTCAE.', 'timeFrame': '5 years'}, {'measure': 'To report on longitudinal QOL using EORTC QLQ C-30 (English, Hindi, Marathi as applicable)', 'timeFrame': '5 years'}, {'measure': 'To report on longitudinal QOL using EORTC VU-34 (English, Hindi, Marathi as applicable)', 'timeFrame': '5 Years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiotherapy'], 'conditions': ['Vulvo-vaginal Cancer']}, 'descriptionModule': {'briefSummary': 'The vaginal cancers are responsible for 2% of gynecological cancer while vulvar cancers account for 4 % of gynecological cancers. HPV 16 and 33 are most prevalent in vaginal cancers and account for more than half of cases HPV related vaginal cancer. However, adeqaute information is not there. Similarly, structured QOL data is not available for India. Therefore, in the proposed study we will like to systematically evaluate the patterns of relapse and disease outcomes in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy). The therapeutic research in vulvo-vaginal cancers has been relatively slow and such structured registration databases can allow analysis of large number of patients to report on acute and late effect of treatment outcomes using CTCAE and QOL (EORTC QLQ C-30 and VU-34) in rare cancers. We hope that we will get help in identifying thrust areas for future research including prospective interventional trials through this study.', 'detailedDescription': 'This study will be conducted in two parts:\n\nRetrospective (Cohort A; Waiver of consent requested) This cohort will include patients treated between January 1, 2019 - August 31st, 2021 (or till time of approval of the present IRB application) which will be part of MD thesis of Dr. Priyanshu Tripathi. In these patients only clinic- pathological information will be extracted from the EMR. This cohort will contribute towards the primary objective and secondary endpoints 1 and 2 only. Waiver of consent for this cohort will be applied. Also waiver will be requested for use of available tissue blocks in department of pathology for IHC work. QOL assessment will not be done for this cohort.\n\nProspective registration study (Cohort B; Study specific consent to be obtained) wherein patients undergoing radical chemo- radiation and details about outcome and pattern of relapse will be studied. This cohort will include patients treated after the IEC approval of this study. These patients will be consented for prospective inclusion of their clinical, pathological, treatment, toxicity and quality of life data collection. . It will be MD thesis of next students. Additionally consent will be obtained for immuno- histochemistry work on the available tissue blocks.\n\nFrom electronic medical records and radiotherapy information system the details of tumour volume, stage, nodal involvement, baseline hemoglobin,albumin and histological subtype will be obtained. Details of external radiation, concurrent chemotherapy, brachytherapy dose and nodal disease will be obtained. Paper and eCRF will be used to capture data for prospective cohort and only eCRF (SPSS version 20.0)entries will be done for retrospective cohort. Follow up information will be obtained for clinical and radiological evaluations and patterns of relapse in reference to baseline stage will be reported.\n\nTreatment related acute and late sequelae will be recorded using CTCAE version 5.0 For Cohort B longitudinal evaluation of QOL will be performed using the English, Hindi and Marathi version of VU-34 (translations completed with EORTC and Pilot testing project submitted separately) Uni-variate and multivariate analysis will be performed to evaluate impact of various prognostic factors for overall outcome.\n\nBaseline paraffin blocks will be obtained and IHV staining will be performed for p16, AKT and PDL-1 pathway and correlated with clinical outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include patients who have completed radiation treatment for vulvo-vaginal cancer, and who are undergoing radiation treatment for vulvo-vaginal cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients diagnosed with vulvo- vaginal cancer.\n2. Patients treated with Radiation+/- chemotherapy+/-surgery from January 1, 2019- December 31, 2023.\n\nExclusion Criteria:\n\n1. Patients with Metastatic disease at the presentation.\n2. Incomplete information on the EMR.'}, 'identificationModule': {'nctId': 'NCT07179757', 'briefTitle': 'Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tata Memorial Hospital'}, 'officialTitle': 'Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study.', 'orgStudyIdInfo': {'id': 'TMH IEC1 3814'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'n= 80 Retrospective Cohort'}, {'label': 'Cohort B', 'description': 'n=120 Prospective Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Supriya J Sastri, MD', 'role': 'CONTACT', 'email': 'supriyasastri@gmail.com', 'phone': '9930958309'}, {'name': 'Jayant Goda, MD', 'role': 'CONTACT', 'email': 'godajayantsastri@gmail.comFacility', 'phone': '24177000', 'phoneExt': '7027'}], 'facility': 'Tata Memorial Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'centralContacts': [{'name': 'Dr. Supriya Chopra', 'role': 'CONTACT', 'email': 'supriyasastri@gmail.com', 'phone': '+022-68735000', 'phoneExt': '5113'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Memorial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Radiation Oncology, Gynecology Disease Management Group', 'investigatorFullName': 'Supriya Sastri (chopra)', 'investigatorAffiliation': 'Tata Memorial Hospital'}}}}