Molecular Classification in Mexican Patients With Endometrial Cancer and Its Impact on Prognosis

NCT06206083 | Recruiting

• 1 other identifier: (023/028/ICI/(CEI/017/23)
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Endometrial cancer (EC) is one of the most common gynecological neoplasms, being the second in incidence and third in mortality in Mexico. Recent studies show that EC molecular classification (Cancer Genome Atlas Research Network, 2013) serves to establish a more accurate prognosis in these patients and regulate therapeutic behavior in a personalized manner. However, there are no studies on EC molecular classification in Mexican women or its impact on prognosis and the possible modification of targeted treatment. The investigators will determine the molecular classification in EC by next-generation sequencing (NGS) to detect TP53 and POLE somatic mutations, and immunohistochemical detection of microsatellite instability (MSH2, MLH1, PMS1, PMS2, MSH6, and MSH3) in a cohort of patients with endometrioid-type EC, endometrioid subtype, attended at the Instituto Nacional de Cancerología - Mexico (INCan) and determine its impact on clinical prognosis.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer; Prognostic factors

Outcome Measures

Primary Outcomes (4)

• sequence the exome

  Molecular classification of endometroid-type endometrial cancer in Mexican participants based on POLE and TP53 mutations as well as makers of microsatellite instability (MSH2, MLH1, PMS1, PMS2, MSH6, and MSH3).

  2024-2025

• Determine POLE mutations

  Determine POLE mutations by massive next-generation sequencing of a discovery cohort in patients with endometroid-type EC.

  2024-2025

• Determine microsatellite instability

  To perform validation of POLE mutation by real-time PCR in a validation cohort of patients with endometroid-type EC.

  2025-2026

• Validation

  To perform validation of POLE mutation by real-time PCR in a validation cohort of patients with endometroid-type EC.

  2025-2026

Secondary Outcomes (2)

• Overall survival

  2025-2026

• Disease-free surviva

  2025-2026

Study Arms (1)

Patients with EC endometroid

Patients with EC endometroid subtype and peripheral blood, treated during 2015-2019 at the INCan.

Genetic: Descriptive and analytical

Interventions

Descriptive and analytical GENETIC

Patients with EC endometroid

Patients with EC endometroid

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We will evaluate samples from females with endometrioid type EC t
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will evaluate samples from patients with endometrioid type EC treated between 2015-2019. Samples of patients over 18 years of age admitted to the cohort with a diagnosis of endometrioid-type EC are already collected and will be evaluated for exome sequencing (N=32) for the detection of POLE mutations.

You may qualify if:

• Clinical diagnosis of endometrioid-type endometrial cancer with samples available
• That the patients have undergone surgery at INCan.

You may not qualify if:

• Samples with CEE of non-endometroid type.
• Samples from patients with double primary neoplasm, including carcinoma ductal in situ, squamous cell skin cancers, and cervical carcinoma in situ
• History of malignancy \< 5 years prior with no evidence of disease (i.e., remission).

Sponsors & Collaborators

• National Institute of Cancerología: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Instituto Nacional de Cancerología

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin embeamed samples

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

• David F Cantu-de-León, PhD

  The Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David F Cantu-de-León, PhD

CONTACT

+52-55-5628-0400; dfcantu@gmail.com

Diddier Prada, PhD

CONTACT

+52-55-41-42-18-02; pradadiddier@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Medical Sciences; Researcher in Medical Sciences

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 16, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Any time by direct request to the principal investigator
• Access Criteria: Only for research purposes.

Locations

ME (1)