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

NCT ID: NCT06071286

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-19
• Study Completion Date: 2026-10-30

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Interventional

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

Group Type: EXPERIMENTAL

Blood samples

Intervention Type: PROCEDURE

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

Interventions

Blood samples

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camilla Nero, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Camilla Nero, PhD

Role: CONTACT

camilla.nero@policlinicogemelli.it

0630158667

Francesca Sillano

Role: CONTACT

francesca.sillano@policlinicogemelli.it

0630158667

Facility Contacts

Camilla Nero, PHD

Role: primary

camilla.nero@policlinicogemelli.it

0630158667

Other Identifiers

6065

Identifier Type: -

Identifier Source: org_study_id