NCT05462951CompletedNot Applicable
Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Denise Fabian2 sites in 1 country19 target enrollmentStarted: January 3, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Biomarker
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Radiochemotherapy followed by brachytherapy
Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy
Intervention: Standard (Radiation)
Outcomes
Primary Outcomes
Biomarker
Time Frame: 3 months posttherapy
deoxyribonucleotide levels
Secondary Outcomes
No secondary outcomes reported
Investigators
Denise Fabian
Assistant Professor
University of Kentucky
Study Sites (2)
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