Outcomes and quality of life for people with vulvar and vaginal cancer treated with radiation
Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study.
This project will collect clinical, treatment, and quality-of-life information to see if patterns of relapse and treatment side effects can be identified in people with vulvo-vaginal cancer who receive radiation, with or without chemotherapy or surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | Female |
| Sponsor | Tata Memorial Hospital Government |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT07179757 on ClinicalTrials.gov |
What this trial studies
This ambispective registration combines a retrospective cohort of patients treated from January 1, 2019 and a prospective cohort enrolled after institutional ethics approval at Tata Memorial Hospital. Clinical, pathological, radiotherapy, toxicity (CTCAE), and quality-of-life data (EORTC QLQ-C30 and VU-34) will be extracted from the electronic medical record and collected prospectively, with planned immunohistochemistry on available tissue blocks. The retrospective arm requests a waiver of consent and will contribute to primary and selected secondary endpoints, while the prospective arm obtains informed consent for ongoing data and QOL collection. The protocol excludes patients with metastatic disease at presentation and those with incomplete medical records.
Who should consider this trial
Good fit: Adults diagnosed with vulvar or vaginal cancer who received radiation (with or without chemotherapy or surgery) at Tata Memorial Hospital, with retrospective records from January 1, 2019 onward and new patients enrolled prospectively after ethics approval.
Not a fit: Patients with metastatic disease at presentation, those with incomplete electronic records, or those not treated at Tata Memorial Hospital are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the registry could clarify relapse patterns and late effects after radiation and help guide follow-up care and the design of future interventional trials.
How similar studies have performed: Structured registries and routine QOL measurement have informed care in other rare cancers, but comparable large-scale, India-specific data for vulvo-vaginal cancers are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mumbai, Maharashtra
- Tata Memorial Hospital — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Study coordinator: Dr. Supriya Chopra
- Email: supriyasastri@gmail.com
- Phone: +022-68735000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.