Vaginal StrictureQRIVSNCT05002751
Quantifying Radiation Induced Vaginal Stenosis
An observational study of Vaginal Stricture and Vaginal Stenosis, run by University of California, San Diego at 1 site in United States.
Trial summary
Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Vaginal Stricture, Vaginal Stenosis
- What is being tested?
- UCSD Vaginal Dilator Questionnaire and EORTC Sexual Health Questionnaire
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 28 Feb 2027
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female subjects over 18 years old, scheduled to receive radiotherapy and/or brachytherapy for the treatment of gynecological cancers.
Who may be able to join
- Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1 interspace.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix II).
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥2,500/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
Show all 18Show fewer
- hemoglobin ≥8 g/dL (can be transfused with red blood cells pre- study)
- total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤3 × ULN
- alkaline phosphatase ≤2.5 × ULN
- creatinine <1.5 mg/dL INR and aPTT ≤1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose.)
- Age is > 18 years.
- Patient does not have a known allergy to cisplatin or compounds of similar biologic composition.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have:
- A stable regimen of highly active anti-retroviral therapy (HAART)
- No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
- A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests.
Who cannot join
- Patients who have received prior radiation therapy to the pelvis or abdominal cavity, PALN radiation, or previous therapy of any kind for this malignancy or pelvic, PALN, or abdominal radiation for any prior malignancy.
- Patients with PALN nodal metastasis above the T12/L1 interspace.
- Patients who had a radical hysterectomy with positive PALNs are not eligible.
- Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Patients previously treated with systemic anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
- Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (with the exception of DCIS of the breast, or early stage basal cell carcinoma of the skin)
- transcription mediated amplification (TMA) or branched DNA testing.
- History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jyoti Mayadev, MD contact
United States1 site, 1 recruiting
- Recruiting
UCSD Moores Cancer Center
La Jolla, California, 92093
Gerald Henderson, BA, 858-822-5223, gehenderson@health.ucsd.edu
About this study
Official title: Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device
Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements.
In addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.
Read the detailed description
This single-arm pilot will enroll 12 subjects scheduled to receive radiotherapy or brachytherapy for gynecological cancers. The study will collect data from CT images, physical measurements, patient reported outcomes to develop a quantifiable generalizable metric for determining the severity of radiotherapy/brachytherapy induced vaginal stenosis.
The data will be used to inform the development of a novel personalized device for the treatment of vaginal stenosis.
- Conditions
- Vaginal Stricture, Vaginal Stenosis
- Being tested
- UCSD Vaginal Dilator Questionnaire, EORTC Sexual Health Questionnaire
- Keywords
- Vaginal Stenosis, Vaginal Stricture, Radiotherapy Side Effect, Brachytherapy Side Effect
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCSD Vaginal Dilator QuestionnaireOther
14 question survey
EORTC Sexual Health QuestionnaireOther
22 question survey
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 1. Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1 interspace. Receives: Other: UCSD Vaginal Dilator Questionnaire; Other: EORTC Sexual Health Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify radiation induced vaginal stenosis
acquire and integrate imaging and direct patient vaginal diameter measurements to characterize VS for the computer and benchtop models
Measured: 1.5 years
Acquire Patients' Treatment Concerns and Preferences
Using a series of sexual and vaginal health questionnaires presenting an array of scaled (quantified) options we will determine patients' perceived flaws about current treatment and their preferences, and integrate them with the VS measurement results of Aim1 to guide modification and optimization of our soft balloon VS treatment system
Measured: 1.5 years
Optimize and Validate Vaginal Stenosis Treatment System
Incorporating the multimodal vaginal stenosis measurements and patient preferences acquired in Aim 1, we will use computer modelling based on known vaginal wall properties to simulate and predict the long-term outcomes of balloon-driven, graded vaginal expansion to counteract VS. Benchtop experimentation will utilize an inflatable balloon-type device and 3D printed biomimetic stenosed vaginal phantoms to test the proposed treatment effect over various time periods emulating different stages of fibrotic stenosis. To directly test our working hypothesis results acquired from modeling will be compared statistically to benchtop data.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start6 Oct 2022
- Primary completion5 Apr 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal StrictureStudies 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
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jyoti Mayadev, MD, University of California, San Diego
- Investigators
- Jyoti Mayadev, MD, Principal investigator, University of California, San Diego Moores Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002751
- Sponsor's protocol ID
- QRIVS-001
- Other IDs
- PAR 20-292, PAR 20-292
- Acronym
- QRIVS
- Status last verified
- Jul 2025
- First submitted
- 4 Aug 2021
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device
- ClinicalTrials.gov ID
- NCT05002751
- Acronym / sponsor ID
- QRIVS / QRIVS-001
- Conditions
- Vaginal Stricture, Vaginal Stenosis
- Keywords
- Vaginal Stenosis, Vaginal Stricture, Radiotherapy Side Effect, Brachytherapy Side Effect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 5 Apr 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 12 Aug 2021 (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.
Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements.
In addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.
Detailed description
This single-arm pilot will enroll 12 subjects scheduled to receive radiotherapy or brachytherapy for gynecological cancers. The study will collect data from CT images, physical measurements, patient reported outcomes to develop a quantifiable generalizable metric for determining the severity of radiotherapy/brachytherapy induced vaginal stenosis.
The data will be used to inform the development of a novel personalized device for the treatment of vaginal stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: UCSD Vaginal Dilator Questionnaire, Other: EORTC Sexual Health Questionnaire1. Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1 interspace. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female subjects over 18 years old, scheduled to receive radiotherapy and/or brachytherapy for the treatment of gynecological cancers.
Key inclusion criteria (18 listed)
- Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1 interspace.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix II).
- Patients must have normal organ and marrow function as defined below:
- Age is > 18 years.
- Patient does not have a known allergy to cisplatin or compounds of similar biologic composition.
Key exclusion criteria (8 listed)
- Patients who have received prior radiation therapy to the pelvis or abdominal cavity, PALN radiation, or previous therapy of any kind for this malignancy or pelvic, PALN, or abdominal radiation for any prior malignancy.
- Patients with PALN nodal metastasis above the T12/L1 interspace.
- Patients who had a radical hysterectomy with positive PALNs are not eligible.
- Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Patients previously treated with systemic anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCSD Vaginal Dilator Questionnaire14 question survey | Other | Cohort 1 |
| EORTC Sexual Health Questionnaire22 question survey | Other | Cohort 1 |
Primary outcome
Quantify radiation induced vaginal stenosis
Time frame: 1.5 years
acquire and integrate imaging and direct patient vaginal diameter measurements to characterize VS for the computer and benchtop models
Acquire Patients' Treatment Concerns and Preferences
Time frame: 1.5 years
Using a series of sexual and vaginal health questionnaires presenting an array of scaled (quantified) options we will determine patients' perceived flaws about current treatment and their preferences, and integrate them with the VS measurement results of Aim1 to guide modification and optimization of our soft balloon VS treatment system
Optimize and Validate Vaginal Stenosis Treatment System
Time frame: 1 year
Incorporating the multimodal vaginal stenosis measurements and patient preferences acquired in Aim 1, we will use computer modelling based on known vaginal wall properties to simulate and predict the long-term outcomes of balloon-driven, graded vaginal expansion to counteract VS. Benchtop experimentation will utilize an inflatable balloon-type device and 3D printed biomimetic stenosed vaginal phantoms to test the proposed treatment effect over various time periods emulating different stages of fibrotic stenosis. To directly test our working hypothesis results acquired from modeling will be compared statistically to benchtop data.
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 9 Jul 2025.
- 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.
Jyoti Mayadev, MD contact
Jyoti Mayadev, MD principal investigator
University of California, San Diego Moores Cancer Center
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 Vaginal Stricture and Vaginal Stenosis, run by University of California, San Diego at 1 site in United States.
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 18 inclusion and 8 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 9 Jul 2025. 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 United States. 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 Sandi Matranga, MHA (619-838-9003, smatranga@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify radiation induced vaginal stenosis (time frame: 1.5 years). The study lists 3 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 9 Jul 2025.