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
This trial does not accept healthy volunteersQualifiers
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 population
This is a prospective study enrolling patients with endometrial cancer eligible for fertility-sparing treatment. Data of consecutive patients treated from the 21st of January 2025.
Trial design
Cohort
Prospective
Treatments tested in this trial
Observation only
Other interventionOnly observation following standard of care (histological diagnosis, molecular classification, progestine therapy)
Treatment groups
Trial outcomes
Primary outcomes
Response to fertility sparing treatmetn
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.
Recurrence
To evaluate the recurrence rates of endometrial cancer among these molecular subtypes following fertility-sparing treatment after a CR
Secondary outcomes
Time to CR response
The number of months elapsed from the start of therapy to achieving a complete response.
Obstetric outcomes
After fertility-sparing treatment, we assess outcomes such as pregnancy rate (percentage of individuals achieving pregnancy) and live birth rate (percentage of pregnancies resulting in a live baby) for the cohort.
Sponsors and contacts
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