Analyzing tumor DNA in advanced ovarian cancer patients
SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) TO DETECT MINIMAL RESIDUAL DISEASE AND EARLY RELAPSE IN ADVANCED OVARIAN CANCER PATIENTS
This study is testing if analyzing tumor DNA from blood samples can help doctors predict if advanced ovarian cancer will come back in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Trial ID | NCT06071286 on ClinicalTrials.gov |
What this trial studies
This study focuses on advanced ovarian cancer patients to analyze circulating tumor DNA (ctDNA) from blood samples. The goal is to identify molecular biomarkers that can help predict disease recurrence and assess the risk of relapse. By utilizing ctDNA analysis, the study aims to provide a non-invasive method for monitoring patients and improving clinical decision-making. This approach seeks to address the unmet needs in early detection of recurrence and better understanding of the disease's molecular complexity.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 to 80 with newly diagnosed FIGO stage III A or greater ovarian, fallopian tube, or primary peritoneal cancer.
Not a fit: Patients with a history of any previous cancer in the last 5 years or those who have undergone chemotherapy or targeted treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and early detection of ovarian cancer recurrence, enhancing patient outcomes.
How similar studies have performed: Other studies have shown promise in using ctDNA analysis for cancer monitoring, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Newly diagnosed suspicious International Federation of Gynecology and Obstetrics (FIGO) stage III A or greater ovarian, fallopian tube, or primary peritoneal cancer 2. Age between 18 and 80 years 3. Estimated life expectancy of at least 4 weeks 4. Signed informed consent Exclusion Criteria: 1. Any previous cancer in the last 5 years 2. Previous chemotherapy or target treatments 3. Diagnosis of synchronous tumors 3. Pregnancy or breastfeeding 4. Missed informed consent
Where this trial is running
Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Camilla Nero, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Camilla Nero, PhD
- Email: camilla.nero@policlinicogemelli.it
- Phone: 0630158667
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.