Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation only | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with endometrial cancer eligible for fertility-sparing treatment
- description
- 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.
- interventionNames
- Other: Observation only
Primary outcomes (2)
- measure
- Response to fertility sparing treatmetn
- timeFrame
- 12 months
- description
- To assess the differences in Complete Response (CR), Partial response/stable disease (PR/SD) and progression disease (PD) rates among molecular subtypes (NSMP, POLEmut, p53abn, MMRd/MSI-H) of endometrial cancer in patients undergoing fertility-sparing treatment.
- measure
- Recurrence
- timeFrame
- 12 months
- description
- To evaluate the recurrence rates of endometrial cancer among these molecular subtypes following fertility-sparing treatment after a CR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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). 2. Patients desiring fertility preservation 3. Molecular classification of the tumor using next-generation sequencing (NGS) or Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE). 4. Adequate pre-treatment imaging (MRI or transvaginal ultrasound) confirming no evidence of myometrial invasion or extrauterine spread. Exclusion Criteria: 1. Patients with atypical endometrial hyperplasia or intraepithelial neoplasia 2. Individuals with tumor samples of insufficient quantity or inadequate quality were not included in the analysis 3. Non-endometrioid histology. 4. Patients with a history of prior uterine malignancy or current synchronous malignancies. 5. Medical contraindications to hormonal therapy
References
Publications (0)
Data not yet available