RecruitingNot ApplicableNCT06071286

SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) 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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

30 participants

Start Date

Dec 19, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tracks small pieces of tumor DNA that float in the bloodstream — called circulating tumor DNA (ctDNA) — in women with advanced ovarian cancer. By analyzing this DNA over time, researchers hope to better understand how the cancer changes during treatment and find early signs of recurrence. **You may be eligible if...** - You are between 18 and 80 years old - You have been newly diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer (stage IIIA or higher) - You have not yet received chemotherapy or targeted treatments - You have signed informed consent **You may NOT be eligible if...** - You have had another cancer in the past 5 years - You have received prior chemotherapy or targeted therapy - You have two simultaneous cancers at the same time - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBlood samples

Patients with suspected advanced OC, based on preoperative imaging/clinical evaluation, will undergo blood samples in different timepoints


Locations(1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

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NCT06071286


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