Clinical trial · Observational
Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvo-vaginal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- n= 80 Retrospective Cohort
- label
- Cohort B
- description
- n=120 Prospective Cohort
Primary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available