Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study.

February 3, 2026 updated by: Supriya Sastri (chopra), Tata Memorial Hospital
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study will be conducted in two parts:

Retrospective (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.

Prospective 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.

From 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.

Treatment 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.

Baseline paraffin blocks will be obtained and IHV staining will be performed for p16, AKT and PDL-1 pathway and correlated with clinical outcomes.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  1. All patients diagnosed with vulvo- vaginal cancer.
  2. Patients treated with Radiation+/- chemotherapy+/-surgery from January 1, 2019- December 31, 2023.

Exclusion Criteria:

  1. Patients with Metastatic disease at the presentation.
  2. Incomplete information on the EMR.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort A
n= 80 Retrospective Cohort
Cohort B
n=120 Prospective Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To report patterns of relapse in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy)
Time Frame: 5 years
To Report pattern of relapse in patients measure by Clinical Examination , By taking folllow up and Symptoms Reporting
5 years
To report patterns of disease outcome in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy)
Time Frame: 5 Years
To Report pattern of relapse in patients measure by Clinical Examination , By taking folllow up and Symptoms Reporting
5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To report outcomes as a function of p16, AKT, PDL-1 expression.
Time Frame: 5 years
IHC Staining will be performed for p16, AKT, PDL-1 expression
5 years
To report on acute and late effect of treatment outcomes using CTCAE.
Time Frame: 5 years
5 years
To report on longitudinal QOL using EORTC QLQ C-30 (English, Hindi, Marathi as applicable)
Time Frame: 5 years
5 years
To report on longitudinal QOL using EORTC VU-34 (English, Hindi, Marathi as applicable)
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

August 18, 2025

First Submitted That Met QC Criteria

September 16, 2025

First Posted (Actual)

September 18, 2025

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TMH IEC1 3814

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vulvo-vaginal Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe