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RecruitingNCT07121543Updated Aug 13, 2025

Biological Drivers of Cervical Cancer and Side Effects From Radiation Therapy

An observational study in Cervical Cancer, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by University of California, San Diego · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cervical Cancer

Keywords

  • Radiotherapy
  • Cervical cancer
  • Translational research
  • Biomarkers
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 20 is below the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with cervical cancer.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or lactation
  • Inability to provide a tissue sample
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • RadiationBrachytherapy

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

    Also known as: Internal radiation therapy

06

What researchers measure

Primary outcomes

  1. Tissue factor expression in tumors

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

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • University of California San Diego
    La Jolla, California 92093, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07121543
Lead sponsor
University of California, San Diego
Responsible party
Jyoti Mayadev, MD (Professor, Radiation Medicine and Applied Sciences, University of California, San Diego) — Principal investigator
First posted
Aug 13, 2025
Start date
Aug 4, 2025
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Aug 13, 2025

Study contacts

Jyoti Mayadev, MD
Contact
CancerCTO@health.ucsd.edu
858-822-5354
Erika Peterson
Contact
CancerCTO@health.ucsd.edu
858-822-5354
Jyoti Mayadev, MD
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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