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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Descriptive and analytical
GeneticPatients with EC endometroid
Treatment groups
Trial outcomes
Primary outcomes
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).
Determine POLE mutations
Determine POLE mutations by massive next-generation sequencing of a discovery cohort in patients with endometroid-type EC.
Determine microsatellite instability
To perform validation of POLE mutation by real-time PCR in a validation cohort of patients with endometroid-type EC.
Validation
To perform validation of POLE mutation by real-time PCR in a validation cohort of patients with endometroid-type EC.
Secondary outcomes
Overall survival
To describe the overall survival of molecular types of endometroid-type EC in INCan patients.
Disease-free surviva
To describe the disease-free survival of the molecular types of endometroid-type EC in INCan patients.
Sponsors and contacts
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National Institute of Cancerología
Lead sponsor
GlaxoSmithKline
Collaborator