Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Location status: Recruiting
NCT Number: NCT06071286
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.
Interested in participating?
Request Info18 year–80 year
Female
Interventional
Not applicable
Roma, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with suspected advanced OC, based on preoperative imaging/clinical evaluation, will undergo blood samples in different timepoints
Time frame: 24 months
The primary endpoint is to evaluate the ability of ctDNA to detect OC recurrence earlier than radiology (CT scan and ultrasound examination) and serum biomarkers used in clinical practice, in terms of diagnostic accuracy (i.e. specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV)).
Contact information is provided by the study sponsor or research team.
Camilla Nero, PhD
CONTACT
Francesca Sillano
CONTACT
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) TO DETECT MINIMAL RESIDUAL DISEASE AND EARLY RELAPSE IN ADVANCED OVARIAN CANCER PATIENTS
Acronym: SPEED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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