Testing Tumor DNA in Blood to Study Early-Stage Ovarian Cancer After Surgery
Looks at tumor DNA in archived blood samples from adults with early ovarian cancer.
Plain-language title generated from the registry record
Registry title: Setting Up ctDNA Analysis on Archived Plasma Samples
Key facts
- Where
- Roma, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study looks at stored blood plasma samples from women with epithelial ovarian cancer who had surgery to remove all visible disease. It tests tumour DNA in the blood before and after surgery.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Epithelial ovarian cancer, FIGO 2014 stage I-IV, other than mucinous type. Surgery was done to remove the disease, with no visible tumour left.
- Earlier treatment
- Had surgery for the cancer with no visible tumour left afterwards.
- Biomarker or test result
- Two stored plasma samples are needed: one before surgery and one 4-7 weeks after surgery, at least 4 ml each.
Main reasons for not taking part
- No clinical data available
- Less than 6 months of follow-up after surgery
- Another cancer diagnosed in the previous 5 years
- One or both of the two plasma samples missing
Read by machine on 12 November 2026.
Where in Italy
- Policlinico Universitario A. Gemelli IRCCSRoma, ItalyContact: Camilla Nero, MD PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT07546578
- Record updated
- 11 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Less than 6 months of follow-up from surgery; Diagnosis of other malignancies in the previous 5 years; Absence of clinical data; Absence of one or both of the prespecified timepoints.