NCT07746024Active, not recruiting
Advancing Risk Stratification in Endometrial Cancer
Advancing Risk Stratification in Endometrial Cancer: Integrating Dynamic Circulating Tumor DNA and Proteomics-Based Liquid Biopsies for Enhanced Prognostic Precision
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
The DaPHNE study is an observational, ambispective, multicenter study designed to evaluate whether the integration of circulating tumor DNA (ctDNA) and plasma proteomic profiling with the 2023 FIGO staging system improves prognostic stratification in patients with endometrial cancer (EC) treated with curative-intent surgery. The study will compare the prognostic performance of the standard FIGO 2023 staging system with an enhanced longitudinal staging approach (L-FIGO 2023) incorporating preoperative (T0) and postoperative (T1, 4-6 weeks after surgery) liquid biopsy data, and will explore a dynamic model (Δ-FIGO) based on changes between these time points. The study consists of two phases: (1) a retrospective cohort including approximately 300 patients with stored plasma samples and clinical data, and (2) a prospective cohort of 100 newly enrolled patients from participating centers. Plasma samples will undergo ctDNA sequencing, methylation analysis, and proteomic profiling using next-generation sequencing and Olink technologies. Molecular findings will be integrated with clinicopathological and survival data to identify biomarkers associated with minimal residual disease, recurrence, and progression-free survival, validate multimodal prognostic models across institutions, assess concordance between circulating and tissue biomarkers, and identify molecular pathways relevant for personalized treatment strategies. The primary endpoint is progression-free survival.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 28 Jul 2026
- Start date
- 23 Jul 2026
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Endometrial cancer
- NCT number
- NCT07746024
What you commit to
- Study type: Observational
- Planned participants: 400
- From 23 Jul 2026 to the primary completion date, 1 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received prior systemic anticancer therapy;
Other illness
- HIV, HBV or HCV-infected participants;
- Patients with synchronous cancers.
Other
- Has persistent, recurrent, or newly diagnosed metastatic EC that is not amenable to curative treatment;
Who the study is looking for
- Women aged 18 or older
- Has a histologically confirmed new diagnosis of EC, regardless of histologic subtype or grade;
- EC staged according to the 2023 FIGO classification, with complete molecular assessment;
- Eligible for curative-intent debulking surgery with no residual disease at the end of surgery;
- No history of other malignancies within the preceding 3 years, except for curatively treated cervical carcinoma in situ, basal cell carcinoma of the skin, or ductal carcinoma in situ of the breast;
- For patients included in the prospective cohort, written informed consent will be obtained, whereas for those included in the retrospective cohort, reference will be made to Article 110-bis of the Italian Privacy Code
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.