NCT06799624

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Jan 2028

First Submitted

Initial submission to the registry

January 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

December 23, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

January 23, 2025

Last Update Submit

December 16, 2025

Conditions

Uterine Cancer

Keywords

uterine cancerfertility-sparingmolecular classification

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 months

  • Recurrence

    To evaluate the recurrence rates of endometrial cancer among these molecular subtypes following fertility-sparing treatment after a CR

    12 months

Secondary Outcomes (2)

  • Time to CR response

    12 months

  • Obstetric outcomes

    12 mesi

Study Arms (1)

Patients with endometrial cancer eligible for fertility-sparing treatment

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.

Other: Observation only

Interventions

Observation onlyOTHER

Only observation following standard of care (histological diagnosis, molecular classification, progestine therapy)

Patients with endometrial cancer eligible for fertility-sparing treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients with endometrial cancer eligible for fertility-sparing treatment.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Medical contraindications to hormonal therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Michigan, 20133, Italy

Location

MeSH Terms

Conditions

Uterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Filippo Ferrari, MD

CONTACT

3803933116filippo.ferrari@istitutotumori.mi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2025

First Posted

January 29, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

December 23, 2025

Record last verified: 2025-01

Locations

IT(1)