Quantifying Radiation Induced Vaginal Stenosis

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT05002751
Status
Recruiting
Apply to this trial

Conditions

  • Vaginal Stenosis
  • Vaginal Stricture

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • UCSD Vaginal Dilator Questionnaire — OTHER
    14 question survey
  • EORTC Sexual Health Questionnaire — OTHER
    22 question survey

Study Details

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.

Key Dates

Start date
Oct 6, 2022
Status verified
Jul 2025
Primary completion
Apr 5, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
12 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Quantify radiation induced vaginal stenosis [ Time Frame: 1.5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSD Moores Cancer CenterLa JollaCalifornia92093
Gerald Henderson, BA
[email protected]
858-822-5223

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By research site
UCSD Moores Cancer Center· La Jolla, CA

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