MedTrace Logo

Advancing Risk Stratification in Endometrial Cancer

NCT07746024 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-08-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Liquid Biopsy

Collection and analysis of peripheral blood samples obtained before surgery (T0) and 4-6 weeks after surgery (T1) for circulating tumor DNA (ctDNA), DNA methylation, and plasma proteomic profiling.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Camilla Nero · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-23
Primary Completion
2027-08-01
Completion
2029-08-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07746024 on ClinicalTrials.gov