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NCT Number: NCT06206083

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Nacional de Cancerología

Mexico City, 14080, Mexico

Location status: Recruiting

About this study

The investigators will carry out a pilot study on 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) and the detection of POLE mutations. DNA will be extracted using the "DNA/RNA AllPrep" kit (QIAGEN). Verification of adequate DNA extraction will be performed by quantifying using TapeStation (Agilent). Exome sequencing (N = 32 tumor samples and 32 somatic samples [leukocytes] from the same patient) will be carried out using Illumina's Nextera Rapid Capture Exome at Azenta Life Science (NJ, USA) following preset protocols and with a depth of 100X. The alignment and detection of variants will be done with the GATX-Mutect Suite (Broad Institute, USA) and the annotation of variant filtering with ANNOVAR. The identification of hotspots will be made according to Chen study. The immunohistochemistry (IHC) for microsatellite instability and overexpressed mutant TP53 (N = 94) will be done using established IHC protocols and will include MSH2, MLH1, PMS1, PMS2, MSH6, MSH3, and TP53.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Criteria: Inclusion Criteria:

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

Exclusion criteria

  • 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).

Treatment and study plan

Descriptive and analytical

Genetic

Patients with EC endometroid

Primary outcomes

  1. sequence the exome

    Time frame: 2024-2025

    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).

  2. Determine POLE mutations

    Time frame: 2024-2025

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

  3. Determine microsatellite instability

    Time frame: 2025-2026

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

  4. Validation

    Time frame: 2025-2026

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

Secondary outcomes

  1. Overall survival

    Time frame: 2025-2026

    To describe the overall survival of molecular types of endometroid-type EC in INCan patients.

  2. Disease-free surviva

    Time frame: 2025-2026

    To describe the disease-free survival of the molecular types of endometroid-type EC in INCan patients.

Study contacts

Contact information is provided by the study sponsor or research team.

David F Cantu-de-León, PhD

CONTACT

[email protected]

+52-55-5628-0400 ext. 21016

Diddier Prada, PhD

CONTACT

[email protected]

+52-55-41-42-18-02

Sponsors and collaborators

Lead sponsor

National Institute of Cancerología

Other Gov

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 16, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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