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Studying molecular types of womb cancer in patients who wish to keep fertility

Observes how molecular tumor types relate to outcomes in younger women with womb cancer.

Plain-language title generated from the registry record
Registry title: Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr

Key facts

Where
Milan, ItalySee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 50 years old?

Source: NCT06799624, who can take part

Where in Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori di MilanoMilan, ItalyNo longer taking part

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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Trial details

Who runs it
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Trial code
NCT06799624
Record updated
23 December 2025
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Patients with a history of prior uterine malignancy or current synchronous malignancies; Medical contraindications to hormonal therapy; 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.

ClinicalTrials.gov NCT06799624