Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Not Applicable

Recruiting

• Conditions: Uterine Cervix Cancer

• Registration Number: NCT05462951
• Lead Sponsor: Denise Fabian

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Study Start: 2023-01-03
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-18
• Last Update Posted: 2025-08-19
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Biomarker	3 months posttherapy	Circulating tumor cell count

Trial Locations

Locations (1)

Markey Cancer Center; 🇺🇸 Lexington, Kentucky, United States