NCT06799624Not yet recruiting
Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr
Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr: PREFACE Study
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 23 Jan 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Endometrial cancer
- NCT number
- NCT06799624
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Jan 2026 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a history of prior uterine malignancy or current synchronous malignancies.
- Medical contraindications to hormonal therapy
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori di Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.