Setting Up ctDNA Analysis on Archived Plasma Samples (DARE-part1)

April 20, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Setting Up ctDNA Analysis on Archived Plasma Samples to Personalize Adjuvant Treatment in Early-Stage Ovarian Cancer

This study (DARE part 1) is a single-center, retrospective, observational feasibility study promoted by the Fondazione Policlinico Universitario Agostino Gemelli IRCCS and co-funded by Fondazione AIRC, aimed at evaluating the clinical utility of circulating tumor DNA (ctDNA) for the assessment of minimal residual disease (MRD) in patients with epithelial ovarian cancer (EOC). In early-stage EOC, the current standard of care consists of complete surgical staging followed by platinum-based adjuvant chemotherapy in high-risk patients; however, the benefit of adjuvant treatment remains controversial in optimally staged cases, as no clear overall survival advantage has been demonstrated. Previous evidence has highlighted the limitations of conventional staging and the need for more accurate biomarkers to identify patients at higher risk of recurrence. ctDNA has emerged as a promising non-invasive biomarker for MRD detection and prognosis in several malignancies, including EOC, but its role in early-stage disease following curative surgery is still uncertain and has not yet been explored in registered studies guiding adjuvant treatment decisions.

The study will retrospectively analyze paired pre-operative (T0) and post-operative (T1, 4-7 weeks after surgery) plasma samples from 50 patients with epithelial ovarian cancer (excluding mucinous histology) who underwent surgery with curative intent and achieved no macroscopic residual disease. All samples were previously collected between January 2022 and June 2025 within other approved clinical studies and are stored in the institutional biobank. ctDNA analysis will be performed using an advanced next-generation sequencing (NGS) platform integrating genomic and epigenomic profiling, with laboratory analyses conducted by Guardant Health, while clinical and correlation analyses will be carried out by the promoting center. The primary endpoint is ctDNA clearance, defined as a binary change in ctDNA detectability between the pre- and post-surgical timepoints. Secondary endpoints include the correlation of ctDNA status with clinicopathological characteristics such as tumor grade, histological subtype, and FIGO stage, as well as the association between ctDNA detectability and progression-free survival. Statistical analyses will compare paired ctDNA measurements using McNemar's test, while associations with clinical variables and survival outcomes will be explored using logistic regression and Cox proportional hazards models supported by Kaplan-Meier estimates.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with early-stage epithelial ovarian cancer (EOC) for whom blood samples collected between January 2022 and June 2025 are available.

Description

Inclusion Criteria:

  • Epithelial ovarian cancer but mucinous histotype
  • Available matched pre-operative and post-operative (4-7 weeks after surgery) plasma samples
  • Minimum 4 ml of plasma each timepoint
  • FIGO 2014 stage I-IV addressed to surgery with curative intent (no gross residual disease after surgery)

Exclusion Criteria:

  • Absence of clinical data
  • Less than 6 months of follow-up from surgery
  • Diagnosis of other malignancies in the previous 5 years
  • Absence of one or both of the prespecified timepoints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure ctDNA clearance
Time Frame: Baseline
The primary endpoint measure ctDNA clearance through a binary assessment of ctDNA before (T0) and after surgery (T1).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ctDNA levels and clinicopathological features
Time Frame: Baseline
To correlate ctDNA levels and clinicopathological features (grade, histology, stage)
Baseline
ctDNA status and progression-free survival
Time Frame: Baseline
To correlate ctDNA status and progression-free survival (PFS)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Camilla Nero, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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