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NCT Number: NCT07121543

Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California San Diego

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Project Manager

CONTACT

[email protected]

858-822-5354

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brachytherapy

Radiation

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

Other names: Internal radiation therapy

Primary outcomes

  1. Tissue factor expression in tumors

    Time frame: 8 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Erika Peterson

CONTACT

[email protected]

858-822-5354

Jyoti Mayadev, MD

CONTACT

[email protected]

858-822-5354

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Understanding the Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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