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RecruitingNCT05002751QRIVSUpdated Jul 9, 2025

Quantifying Radiation Induced Vaginal Stenosis

An observational study in Vaginal Stricture and Vaginal Stenosis, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by University of California, San Diego · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 4 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 99 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Vaginal Stricture
  • Vaginal Stenosis

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Keywords

  • Vaginal Stenosis
  • Vaginal Stricture
  • Radiotherapy Side Effect
  • Brachytherapy Side Effect
03

In context

Radiation Injuries

108 studies on the registry are indexed under Radiation Injuries; 46 are open to participants now.

This study's planned enrollment of 12 is below the median of 105 across 41 observational studies indexed under Radiation Injuries.

Browse Radiation Injuries studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Female subjects over 18 years old, scheduled to receive radiotherapy and/or brachytherapy for the treatment of gynecological cancers.

Inclusion criteria

  • 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:

    1. leukocytes ≥2,500/mcL
    2. absolute neutrophil count ≥1,500/mcL
    3. platelets ≥100,000/mcL
    4. hemoglobin ≥8 g/dL (can be transfused with red blood cells pre- study)
    5. total bilirubin ≤1.5 × institutional upper limit of normal (ULN)
    6. AST(SGOT)/ALT(SGPT) ≤3 × ULN
    7. alkaline phosphatase ≤2.5 × ULN
    8. 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.

Exclusion criteria

Exclusion Criteria:

  • 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)

    a. 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: UCSD Vaginal Dilator Questionnaire · Other: EORTC Sexual Health Questionnaire

Interventions

  • OtherUCSD Vaginal Dilator Questionnaire

    14 question survey

  • OtherEORTC Sexual Health Questionnaire

    22 question survey

06

What researchers measure

Primary outcomes

  1. Quantify radiation induced vaginal stenosis

    acquire and integrate imaging and direct patient vaginal diameter measurements to characterize VS for the computer and benchtop models

    Time frame: 1.5 years

  2. 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

    Time frame: 1.5 years

  3. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • UCSD Moores Cancer Center
    La Jolla, California 92093, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05002751
Lead sponsor
University of California, San Diego
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
Responsible party
Jyoti Mayadev, MD (Associate Professor, University of California, San Diego) — Principal investigator
First posted
Aug 12, 2021
Start date
Oct 6, 2022
Primary completion
Apr 5, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Jul 9, 2025

Study contacts

Sandi Matranga, MHA
Contact
smatranga@health.ucsd.edu
619-838-9003
Jyoti Mayadev, MD
Contact
jmayadev@health.ucsd.edu
Jyoti Mayadev, MD
principal investigator · University of California, San Diego Moores Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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