ctDNA analysis on archived plasma to gauge minimal residual disease in epithelial ovarian cancer
Official title: Setting Up ctDNA Analysis on Archived Plasma Samples to Personalize Adjuvant Treatment in Early-Stage Ovarian Cancer
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07546578 · Data updated 2026-11-12
A single-center study will test whether ctDNA from archived and current blood samples can help identify minimal residual disease in epithelial ovarian cancer patients after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | June 8, 2026 |
| Main results expected | November 2026 |
| Study ends | February 15, 2027 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT07546578 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with epithelial ovarian cancer (non-mucinous histotype) who have undergone surgery with curative intent and have matched pre-operative and post-operative plasma samples available.
✕Probably not a fit
Patients without available plasma samples or insufficient follow-up may not benefit, and those with mucinous histology or other malignancies may not be applicable.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This retrospective observational feasibility study will analyze circulating tumor DNA (ctDNA) from pre-operative and post-operative plasma samples to see if ctDNA reflects residual disease and could help predict recurrence. The study is conducted at a single center and is promoted by a major Italian hospital with co-funding support, focusing on the utility of ctDNA in epithelial ovarian cancer. Eligible participants have epithelial ovarian cancer of non-m mucinous histotype, with adequate plasma samples and curative-intent surgery, and are followed for at least six months. The primary aim is to determine if ctDNA can serve as a non-invasive biomarker for MRD and prognosis in this setting. The study does not involve an intervention beyond analysis of collected samples.
Why it matters
Potential benefit: If successful, ctDNA testing could provide a non-invasive way to identify patients at higher risk of recurrence after surgery.
How similar studies have gone: Previous research has shown ctDNA has potential as an MRD biomarker in several cancers, including ovarian cancer, supporting exploration in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Policlinico Universitario A. Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Camilla Nero — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Camilla Nero, MD PhD
- Email: camilla.nero@policlinicogemelli.it
- Phone: +390630157958
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.