NCT06071286 SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) IN ADVANCED OVARIAN CANCER PATIENTS
| NCT ID | NCT06071286 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-12-19 |
| Primary Completion | 2026-10-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-12-19 with a primary completion date of 2026-10-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ovarian cancer (OC) is the third most common gynaecologic cancer worldwide and has the highest mortality rate among gynaecologic cancers. Despite the advances in cytoreductive surgery and frontline chemotherapy, recurrence is a common event in the advanced disease setting, with more than 70% of women experiencing relapse within two years from diagnosis. New strategies to anticipate the diagnosis of recurrence have been investigated in the last years. In this context, standard serum biomarkers, such as CA-125, and radiological evaluation are commonly used for disease surveillance, However, the early identification of relapsed disease as well as the identification of patients at higher risk for recurrence are still unmetclinical needs. Novel and reliable molecular biomarkers, which might also better represent the intrinsic molecular complexity of OC, could help clinicians to address this important challenge. Circulating tumor DNA (ctDNA) analysis has recently emerged as a non-invasive tool to profile and monitor tumor evolution over time. CtDNA has been extensively studied in several neoplasms in order to evaluate its ability in anticipating detection of relapse compared to common markers used in clinical practice. Wehave designed a study to assess the ability of ctDNA to detect recurrence and progression of disease and to provide a genomic characterization, during follow-up of patients with advanced OC. If proven effective and reliable, ctDNA could be introduced into routine surveillance programme for OC.
Eligibility 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
Contact & Investigator
Camilla Nero, PhD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06071286 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06071286 currently recruiting?
Yes, NCT06071286 is actively recruiting participants. Contact the research team at camilla.nero@policlinicogemelli.it for enrollment information.
Where is the NCT06071286 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06071286 clinical trial?
NCT06071286 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Camilla Nero, PhD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 30 participants.
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