Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy

NCT07121543 | Recruiting

• 1 other identifier: 811012
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn more about the biology of cervical cancer in women who receive radiation therapy for this condition. The main question it aims to answer is: Does radiation therapy alter the expression of tissue factor and other molecules in cervical cancer over time? Participants already scheduled for radiation therapy for cervical cancer as part of their regular medical care will provide blood and biopsies of cervical cancer or of the upper portion of the vagina before, during, and on the last day of radiation therapy.

Conditions

Cervical Cancer

Keywords

Radiotherapy; Cervical cancer; Translational research; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Tissue factor expression in tumors

  Determine the temporal changes of tissue factor expression in the irradiated tumor immune microenvironment.

  8 weeks

Study Arms (2)

Cervical cancer biopsy

Using tumor biopsies collected before, during, and after radiotherapy, the investigators will: 1. Evaluate if irradiation alters tissue factor expression in tumors. 2. Determine the temporal changes of biomarkers in the irradiated tumor immune microenvironment.

Radiation: Brachytherapy

Vaginal apex biopsy

Using vaginal tissue biopsies collected before, during, and after radiotherapy, the investigators will: 1. Evaluate if irradiation alters biomarkers of fibrosis in the vaginal tissue. 2. Determine the temporal changes of inflammatory biomarkers that increases the stenosis molecular cascade in the irradiated tumor immune microenvironment.

Radiation: Brachytherapy

Interventions

Brachytherapy RADIATION

Brachytherapy is a cancer treatment where radioactive sources are placed inside or near the tumor.

Also known as: Internal radiation therapy

Cervical cancer biopsy; Vaginal apex biopsy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cervical cancer.

You may qualify if:

• Age 18 years or older
• Pathological diagnosis of cervical cancer
• Scheduled to receive brachytherapy for cervical cancer

You may not qualify if:

• Pregnancy or lactation
• Inability to provide a tissue sample

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cervical cancer biopsies and blood collected longitudinally from participants with cervical cancer before, during and after radiotherapy. Vaginal tissue biopsies and blood collected longitudinally from participants with cervical cancer before, during and after radiotherapy.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Jyoti Mayadev, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyoti Mayadev, MD

CONTACT

858-822-5354; CancerCTO@health.ucsd.edu

Erika Peterson

CONTACT

858-822-5354; CancerCTO@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiation Medicine and Applied Sciences

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)