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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNational Institute of Cancerología

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of endometrioid-type endometrial cancer with samples available

That the patients have undergone surgery at INCan.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Descriptive and analytical

    Genetic

    Patients with EC endometroid

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: Patients with EC endometroid1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
2024-2025
2

Determine POLE mutations

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

Time frame
2024-2025
3

Determine microsatellite instability

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

Time frame
2025-2026
4

Validation

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

Time frame
2025-2026

Secondary outcomes

1

Overall survival

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

Time frame
2025-2026
2

Disease-free surviva

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

Time frame
2025-2026

Other outcomes

Sponsors and contacts

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