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

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study ID
NCT06799624
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Observation only — OTHER
    Only observation following standard of care (histological diagnosis, molecular classification, progestine therapy)

Study Details

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.

Key Dates

First listed
Jan 29, 2025
Start date
Jan 1, 2026
Status verified
Jan 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Patients with endometrial cancer eligible for fertility-sparing treatment
    Patients diagnosed with endometrial cancer who meet the criteria for inclusion in a fertility-sparing treatment pathway and for whom molecular classification data is available.

Primary Outcome Measure

Response to fertility sparing treatmetn [ Time Frame: 12 months ]

Central Contacts

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