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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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.

Eligibility criteria

Qualifiers

Patients aged 18-45 years with a hysteroscopic confirmed diagnosis of endometrial cancer (FIGO stage IA without myometrial invasion, grade 1 or grade 2, endometrioid histology).

Patients desiring fertility preservation

Molecular classification of the tumor using next-generation sequencing (NGS) or Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE).

Adequate pre-treatment imaging (MRI or transvaginal ultrasound) confirming no evidence of myometrial invasion or extrauterine spread.

Disqualifiers

Patients with atypical endometrial hyperplasia or intraepithelial neoplasia

Individuals with tumor samples of insufficient quantity or inadequate quality were not included in the analysis

Non-endometrioid histology.

Patients with a history of prior uterine malignancy or current synchronous malignancies.

Trial design

Treatments tested in this trial

  • Observation only

Treatment groups

100 Participants
are divided into 1 treatment group