Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

Purpose

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.

Condition

  • Uterine Cervix Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Radiochemotherapy followed by brachytherapy Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy
  • Radiation: Standard
    Radiation then brachytherapy

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Yvonne Taul, RN
859-323-2354
Yvonne.Taul@uky.edu

More Details

NCT ID
NCT05462951
Status
Recruiting
Sponsor
Denise Fabian

Study Contact

Yvonne Taul
859-323-2354
yvonne.taul@uky.edu