Endometrial Cancer Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | February 1, 2027 |
Est. primary completion date | November 1, 2026 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Cancerología | Mexico City | Cdmx |
Lead Sponsor | Collaborator |
---|---|
National Institute of Cancerología | GlaxoSmithKline |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Determine POLE mutations | Determine POLE mutations by massive next-generation sequencing of a discovery cohort in patients with endometroid-type EC. | 2024-2025 | |
Primary | 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 | |
Primary | Validation | To perform validation of POLE mutation by real-time PCR in a validation cohort of patients with endometroid-type EC. | 2025-2026 | |
Secondary | Overall survival | To describe the overall survival of molecular types of endometroid-type EC in INCan patients. | 2025-2026 | |
Secondary | Disease-free surviva | To describe the disease-free survival of the molecular types of endometroid-type EC in INCan patients. | 2025-2026 |
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