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Quantifying Radiation Induced Vaginal Stenosis (QRIVS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05002751
Recruitment Status : Not yet recruiting
First Posted : August 12, 2021
Last Update Posted : September 20, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jyoti Mayadev, MD, University of California, San Diego

Brief 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.


Condition or disease Intervention/treatment
Vaginal Stricture Vaginal Stenosis Other: UCSD Vaginal Dilator Questionnaire Other: EORTC Sexual Health Questionnaire

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.

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2023

Group/Cohort Intervention/treatment
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
14 question survey

Other: EORTC Sexual Health Questionnaire
22 question survey




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05002751


Contacts
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Contact: Gerald Henderson, BA 858-534-4811 gehenderson@health.ucsd.edu
Contact: Jyoti Mayadev, MD jmayadev@health.ucsd.edu

Locations
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United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jyoti Mayadev, MD University of California, San Diego Moores Cancer Center
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Responsible Party: Jyoti Mayadev, MD, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05002751    
Other Study ID Numbers: QRIVS-001
PAR 20-292 ( Other Identifier: National Istitutes of Healh (NIH) )
PAR 20-292 ( Other Identifier: National Cancer Institute (NCI) )
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jyoti Mayadev, MD, University of California, San Diego:
Vaginal Stenosis
Vaginal Stricture
Radiotherapy Side Effect
Brachytherapy Side Effect
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical