Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

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: Recruiting
• Conditions: Uterine Cervix Cancer
• Intervention / Treatment: Radiation: Standard

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yvonne Taul; Phone Number: 859-323-2354; Email: yvonne.taul@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • Markey Cancer Center
      • Contact: Yvonne Taul, RN; Phone Number: 859-323-2354; Email: yvonne.taul@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	deoxyribonucleotide levels	3 months posttherapy
Biomarker	HPV DNA levels	3 months posttherapy
Biomarker	Circulating tumor cell count	3 months posttherapy

Collaborators and Investigators

• Sponsor: Denise Fabian
• Collaborators: UK Radiopharma Alliance
• Investigators: Principal Investigator: Denise Fabian, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 31, 2024

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): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• 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