Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
NCT06071286

SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) IN ADVANCED OVARIAN CANCER PATIENTS

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-02-11

30

Participants Needed

1

Research Sites

198 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) IN ADVANCED OVARIAN CANCER PATIENTS

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed suspicious International Federation of Gynecology and Obstetrics (FIGO) stage III A or greater ovarian, fallopian tube, or primary peritoneal cancer
  • Age between 18 and 80 years
  • Estimated life expectancy of at least 4 weeks
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Any previous cancer in the last 5 years
  • Previous chemotherapy or target treatments
  • Diagnosis of synchronous tumors
  • Pregnancy or breastfeeding
  • Missed informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Actively Recruiting

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Research Team

C

Camilla Nero, PhD

CONTACT

F

Francesca Sillano

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) IN ADVANCED OVARIAN CANCER PATIENTS | DecenTrialz