Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

NCT05462951 | Active Not Recruiting DMC FDA Device

• 1 other identifier: MCC-22-GYN-09
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Cervix Cancer

Outcome Measures

Primary Outcomes (3)

• Biomarker

  deoxyribonucleotide levels

  3 months posttherapy

• Biomarker

  HPV DNA levels

  3 months posttherapy

• Biomarker

  Circulating tumor cell count

  3 months posttherapy

Study Arms (1)

Radiochemotherapy followed by brachytherapy

Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy

Radiation: Standard

Interventions

Standard RADIATION

Radiation then brachytherapy

Radiochemotherapy followed by brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Denise Fabian: lead
• UK Radiopharma Alliance: collaborator

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Denise Fabian, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 18, 2022
• Study Start: January 3, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)