La Jolla, CANCT05002751Now EnrollingIRB Ready

Vaginal Stricture Clinical Trial in La Jolla, CA

Access cutting-edge vaginal stricture treatment through this clinical trial at a research site in La Jolla. Study-provided care at no cost to qualified participants.

Sponsored by University of California, San Diego

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Expert Care in La Jolla

Access vaginal stricture specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related vaginal stricture treatment provided free

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Check if you qualify for this vaginal stricture clinical trial in La Jolla, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to La Jolla

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit La Jolla site if eligible
  4. 4Begin participation

About This Vaginal Stricture Study in La Jolla

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.

Sponsor: University of California, San Diego

Who Can Participate

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:
leukocytes ≥2,500/mcL
absolute neutrophil count ≥1,500/mcL
platelets ≥100,000/mcL
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.

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in La Jolla?

Yes, this clinical trial (NCT05002751) has an active research site in La Jolla, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Vaginal Stricture Treatment Options in La Jolla, CA

If you're searching for vaginal stricture treatment options in La Jolla, CA, this clinical trial (NCT05002751) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our La Jolla research site is actively enrolling participants for this clinical trial. You'll receive care from experienced vaginal stricture specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all vaginal stricture clinical trials near you to find additional studies recruiting in your area.

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