Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Uterine Cervix Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462951
• Other study ID #: MCC-22-GYN-09
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: University of Kentucky
• Contact: Yvonne Taul
• Phone: 859-323-2354
• Email: yvonne.taul[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms
• Uterine Cervix Cancer

Intervention

Radiation:
• Standard
Radiation then brachytherapy

Locations

Country	Name	City	State
United States	Markey Cancer Center	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Denise Fabian	UK Radiopharma Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker	deoxyribonucleotide levels	3 months posttherapy
Primary	Biomarker	HPV DNA levels	3 months posttherapy
Primary	Biomarker	Circulating tumor cell count	3 months posttherapy