Vulvo-vaginal CancerNCT07179757
Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study.
An observational study of Vulvo-vaginal Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vulvo-vaginal Cancer
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 30 Oct 2021to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients diagnosed with vulvo- vaginal cancer.
- Patients treated with Radiation+/- chemotherapy+/-surgery from January 1, 2019- December 31, 2023.
Who cannot join
- Patients with Metastatic disease at the presentation.
- Incomplete information on the EMR.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Supriya J Sastri, MD, 9930958309, supriyasastri@gmail.com
Jayant Goda, MD, 24177000 ext. 7027, godajayantsastri@gmail.comFacility
About this study
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.
Read the 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.
- Conditions
- Vulvo-vaginal Cancer
- Keywords
- Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | n= 80 Retrospective Cohort | |
| Cohort B | n=120 Prospective Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
To report patterns of relapse in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy)
To Report pattern of relapse in patients measure by Clinical Examination , By taking folllow up and Symptoms Reporting
Measured: 5 years
To report patterns of disease outcome in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy)
To Report pattern of relapse in patients measure by Clinical Examination , By taking folllow up and Symptoms Reporting
Measured: 5 Years
Secondary outcomes (4)
To report outcomes as a function of p16, AKT, PDL-1 expression.
IHC Staining will be performed for p16, AKT, PDL-1 expression
Measured: 5 years
To report on acute and late effect of treatment outcomes using CTCAE.
Measured: 5 years
To report on longitudinal QOL using EORTC QLQ C-30 (English, Hindi, Marathi as applicable)
Measured: 5 years
To report on longitudinal QOL using EORTC VU-34 (English, Hindi, Marathi as applicable)
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start30 Oct 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvo-vaginal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Supriya Sastri (chopra), Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179757
- Sponsor's protocol ID
- TMH IEC1 3814
- Status last verified
- Nov 2025
- First submitted
- 18 Aug 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Quality of Life in Patients With Locally Advanced Vulvovaginal Cancers: Ambispective Registration Study.
- ClinicalTrials.gov ID
- NCT07179757
- Acronym / sponsor ID
- TMH IEC1 3814
- Conditions
- Vulvo-vaginal Cancer
- Keywords
- Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –n= 80 Retrospective Cohort |
| Cohort B | – | –n=120 Prospective Cohort |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- All patients diagnosed with vulvo- vaginal cancer.
- Patients treated with Radiation+/- chemotherapy+/-surgery from January 1, 2019- December 31, 2023.
Key exclusion criteria (2 listed)
- Patients with Metastatic disease at the presentation.
- Incomplete information on the EMR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
4 secondary outcomes
To report outcomes as a function of p16, AKT, PDL-1 expression.
Time frame: 5 years
To report on acute and late effect of treatment outcomes using CTCAE.
Time frame: 5 years
To report on longitudinal QOL using EORTC QLQ C-30 (English, Hindi, Marathi as applicable)
Time frame: 5 years
To report on longitudinal QOL using EORTC VU-34 (English, Hindi, Marathi as applicable)
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvo-vaginal Cancer, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Supriya Chopra (+022-68735000 ext. 5113, supriyasastri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To report patterns of relapse in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.