Retrospective ctDNA Feasibility Study in Ovarian Cancer (DARE Part 1)
Summary
A retrospective observational feasibility study (DARE Part 1) was registered on ClinicalTrials.gov (NCT07546578) on April 23, 2026, by Fondazione Policlinico Universitario Agostino Gemelli IRCCS, co-funded by Fondazione AIRC. The study will retrospectively analyze pre- and post-operative plasma samples from 50 epithelial ovarian cancer patients to evaluate the clinical utility of circulating tumor DNA (ctDNA) for assessing minimal residual disease following curative-intent surgery. This registry entry establishes the official study record but does not impose regulatory obligations on other parties.
“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).”
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What changed
A new clinical trial registry entry was added for a single-center retrospective observational feasibility study examining circulating tumor DNA (ctDNA) as a minimal residual disease biomarker in epithelial ovarian cancer. The study will analyze paired plasma samples from 50 patients collected pre- and post-surgery. No regulatory obligations are imposed by this registration; it serves as an informational record of ongoing research.
Affected parties include clinical investigators, oncology researchers, and liquid biopsy developers who may wish to monitor this study for results that could inform future ctDNA-based MRD testing approaches in ovarian cancer. The registry entry provides visibility into emerging biomarker research but does not create compliance requirements.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Setting Up ctDNA Analysis on Archived Plasma Samples
Observational NCT07546578 Kind: OBSERVATIONAL Apr 23, 2026
Abstract
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 be...
Conditions: Ovarian Cancer, Liquid Biopsy
Interventions: ctDNA
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