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
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Radiochemotherapy followed by brachytherapy |
Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Markey Cancer Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT05462951
- Status
- Recruiting
- Sponsor
- Denise Fabian