Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy

University of California San Diego

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Radiation: Brachytherapy

Study type: Observational

Funder types: Other

Identifiers

NCT07121543

811012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Cervical cancer biopsy

Description:

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.

Treatment:

Radiation: Brachytherapy

Vaginal apex biopsy

Description:

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.

Treatment:

Radiation: Brachytherapy