Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy

NCT ID: NCT07121543

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-04

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Brachytherapy

Intervention Type RADIATION

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

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.

Brachytherapy

Intervention Type RADIATION

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

Interventions

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Brachytherapy

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

Intervention Type RADIATION

Other Intervention Names

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Internal radiation therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Jyoti Mayadev, MD

Professor, Radiation Medicine and Applied Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jyoti Mayadev, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California San Diego

La Jolla, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jyoti Mayadev, MD

Role: CONTACT

858-822-5354

Erika Peterson

Role: CONTACT

858-822-5354

Facility Contacts

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Project Manager

Role: primary

858-822-5354

Other Identifiers

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811012

Identifier Type: -

Identifier Source: org_study_id

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