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NCT06071286Recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
3 Oct 2023
Start date
19 Dec 2023
Primary completion date
5 Oct 2026
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT06071286

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 19 Dec 2023 to the primary completion date, 5 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous chemotherapy or target treatments 3. Diagnosis of synchronous tumors

Other illness

  • Any previous cancer in the last 5 years

Other

  • Pregnancy or breastfeeding
  • Missed informed consent

Who the study is looking for

  • 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 4. Signed informed consent

Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.