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NOT YET RECRUITING
NCT06799624

Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr

Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

View on ClinicalTrials.gov

Summary

Endometrial cancer, the most common gynecologic malignancy in high-income countries, is increasing among reproductive-age women. While hysterectomy prevents pregnancy, hormonal therapies offer fertility-sparing options for select early-stage cases, with \~80% achieving complete response (CR). Molecular classifications (POLEmut, p53abn, MMRd/MSI-H, NSMP) reveal subtype-specific prognostic differences, with NSMP showing higher CR rates and lower recurrence, while p53abn and MMRd/MSI-H fare worse. Recent studies emphasize molecular profiling's potential to guide personalized fertility-sparing treatments. This study explores the prognostic role of these classifications in treatment outcomes.

Official title: Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr: PREFACE Study

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-01-01

Completion Date

2028-01-31

Last Updated

2025-12-23

Healthy Volunteers

No

Conditions

Interventions

OTHER

Observation only

Only observation following standard of care (histological diagnosis, molecular classification, progestine therapy)

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Michigan, Italy