Molecular biomarkers in women with cervical cancer
Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
This study is trying to find specific markers in the blood of women with advanced cervical cancer to better understand how the disease progresses and responds to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05462951 on ClinicalTrials.gov |
What this trial studies
This observational clinical trial focuses on women diagnosed with advanced uterine cervix cancer who will receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples will be collected to analyze circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells, aiming to identify molecular biomarkers associated with the disease. The study seeks to enhance understanding of the disease's progression and treatment response through these biomarkers.
Who should consider this trial
Good fit: Ideal candidates are women with untreated stage IB3, II, III, or IVA cervical cancer who are not eligible for curative surgery.
Not a fit: Patients with concurrent active invasive malignancies or those who have had prior pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for women with cervical cancer.
How similar studies have performed: Other studies have explored molecular biomarkers in cancer treatment, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lexington, Kentucky
- Markey Cancer Center — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Denise Fabian, MD — University of Kentucky
- Study coordinator: Yvonne Taul
- Email: yvonne.taul@uky.edu
- Phone: 859-323-2354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.