Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT07121543
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

The standard of care treatment for locally advanced cervical cancer is a combination of chemotherapy with cisplatin and radiotherapy. Although patients have improved outcomes with chemo-radiotherapy, tumor recurrence can occur. In addition, combining chemotherapy with radiotherapy increases treatment-related side effects. While breakthroughs in radiotherapy and immunotherapy have resulted in targeted cancer care, chemotherapy given with radiotherapy is a non-targeted approach. Better strategies to treat cervical cancer are needed.

In this study, the investigators will use tissue and blood from patients with cervical cancer to perform translational research. This is necessary to discover molecular pathways that could be targeted in the future with novel agents, such as radiotherapy and immunotherapy, for the treatment of women with cervical cancer.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-04
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy or lactation
• Inability to provide a tissue sample

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tissue factor expression in tumors	8 weeks	Determine the temporal changes of tissue factor expression in the irradiated tumor immune microenvironment.

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States