REal Word aPpLicAtion of Molecular Based Endometrial Cancer Classification

NCT07555665 | Recruiting

• 1 other identifier: 8149
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the high incidence, endometrial cancer represents a low mortality neoplasma due to the high prevalence of early-stage diagnosis (90%). Concerning the uterine-confined disease (FIGO 2009 and 2023 stage I-II), molecular-based classification has showed an unprecedent impact on the treatment algorithm leading to a full integration into the latest staging classification. The first evidence of the prognostic value of molecular subgroups came from the TCGA data in which patients were subdivided into: patients with POLE gene alterations, MMR deficient (MMRd), patients with TP53 gene mutations, absence of one of these alterations (NSMP). The use of molecular classification reveals distinct prognostic groups ranging from an excellent prognosis (POLE mutated) to those with a worst prognosis (p53 mutated). Therefore, according to the ESGO guidelines, in patients with stage I-II POLE mutated endometrial cancer, the recurrence rate is so low as to justify omitting adjuvant treatment in favor of observation alone. Several groups have applied a diagnostic algorithm using five immunohistochemical markers (p53, MLH1, MSH2, MSH6 and PMS2) and a molecular test (analysis of mutations in the exonuclease domain of POLE) to identify prognostic groups similar to the molecular classification of TCGA. The feasibility of this approach has been confirmed by many publications that have all consistently reported prognostic relevance especially in high-grade and high-risk tumours in several independent cohorts and prospective clinical trials. In conclusion, despite the validation of immunohistochemical evaluation in place of molecular evaluation, the need to perform a more complex evaluation to define POLE status makes its implementation not yet ubiquitous. The integration of molecular analysis of the POLE mutations remains challenging across the centers involved in the management of endometrial cancer. REPLACE is a national, cross-sectional survey that will census all Italian gynaecology centres (≈ 264) involved in the endometrial cancer treatment into: (i) quantify POLE testing adoption, (ii) describe diagnostic methodologies, (iii) map treatment de-escalation strategies triggered by POLE status, and (iv) explore management pathways where POLE is unavailable. Findings will highlight implementation gaps and inform future network initiatives.

Conditions

Endometrial Cancer

Keywords

ENDOMETRIAL CANCER

Outcome Measures

Primary Outcomes (1)

• Prevalence of Routine POLE Testing in Surgical Specimens for Endometrial Cancer Across Italian Gynaecology Units

  To determine the proportion of Italian gynaecology units that perform routine POLE testing in endometrial cancer surgical specimens.

  Baseline

Secondary Outcomes (4)

• Characterization of Laboratory Techniques and Reporting Workflows for POLE Mutation Assessment in Endometrial Cancer

  Baseline

• Impact of POLE Mutation Status on Adjuvant Treatment Decision-Making in Endometrial Cancer.

  Baseline

• Management Pathways and Adoption Readiness in Centres Without POLE Testing for Endometrial Cancer.

  Baseline

• Association Between Centre Characteristics and POLE Testing Uptake and Treatment Patterns in Endometrial Cancer

  Baseline

Study Arms (1)

Survey study asking centers to complete a multiple-choice questionnaire

Survey study asking centers (264 centers) to complete a multiple-choice questionnaire; clinicians have 1 month to respond before a reminder is sent.

Other: Questionnaire Submission

Interventions

Questionnaire Submission OTHER

Questionnaire Submission

Survey study asking centers to complete a multiple-choice questionnaire

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

REPLACE is a national, cross-sectional survey that will census all Italian gynaecology centres (≈ 264) involved in the endometrial cancer treatment into: (i) quantify POLE testing adoption, (ii) describe diagnostic methodologies, (iii) map treatment de-escalation strategies triggered by POLE status, and (iv) explore management pathways where POLE is unavailable. Findings will highlight implementation gaps and inform future network initiatives.

You may qualify if:

• be Italian healthcare hospitals that are involved in the treatment of endometrial carcinoma,
• involved in the surgical management of EC.

You may not qualify if:

• a) declining to participate.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, Roma, 00186, Italy

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Camilla Nero

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Nero CN Camilla Nero, PhD

CONTACT

0630157104; camilla.nero@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: April 29, 2026
• Study Start: November 7, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)