Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

July 1, 2026 updated by: Denise Fabian

Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Markey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is an unblinded phase 0 window-of-opportunity intervention clinical trial to study biomarkers of uterine cervix cancer biology and disease progression in women undergoing cisplatin-based radiochemotherapy for advanced-stage uterine cervix cancer.

Description

Inclusion Criteria:

- Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone.

Exclusion Criteria:

  • Presence of another concurrent active invasive malignancy
  • Prior invasive malignancy diagnosed within the last three years except for [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix
  • prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiochemotherapy followed by brachytherapy
Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy
Radiation: Standard
Radiation then brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker
Time Frame: 3 months posttherapy
deoxyribonucleotide levels
3 months posttherapy
Biomarker
Time Frame: 3 months posttherapy
HPV DNA levels
3 months posttherapy
Biomarker
Time Frame: 3 months posttherapy
Circulating tumor cell count
3 months posttherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denise Fabian

Collaborators

UK Radiopharma Alliance

Investigators

  • Principal Investigator: Denise Fabian, MD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Actual)

June 9, 2025

Study Completion (Actual)

June 9, 2025

Study Registration Dates

First Submitted

July 8, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-22-GYN-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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