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

NCT06071286 | Recruiting

• 1 other identifier: 6065
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To evaluate the ability of ctDNA to detect Ovarian Cancer recurrence. predictive value (NPV)).

  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)).

  24 months

Study Arms (1)

Interventional

EXPERIMENTAL

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

Procedure: Blood samples

Interventions

Blood samples PROCEDURE

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

Interventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any previous cancer in the last 5 years
• Previous chemotherapy or target treatments 3. Diagnosis of synchronous tumors
• Pregnancy or breastfeeding
• Missed informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Camilla Nero, PhD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Nero, PhD

CONTACT

0630158667; camilla.nero@policlinicogemelli.it

Francesca Sillano

CONTACT

0630158667; francesca.sillano@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 6, 2023
• Study Start: December 19, 2023
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 5, 2027
• Last Updated: February 11, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)