Instituto Nacional de Cancerología
Mexico City, 14080, Mexico
Location status: Recruiting
NCT Number: NCT06206083
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Mexico City, 14080, Mexico
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Criteria: Inclusion Criteria:
Exclusion criteria
Patients with EC endometroid
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).
Time frame: 2024-2025
Determine POLE mutations by massive next-generation sequencing of a discovery cohort in patients with endometroid-type EC.
Time frame: 2025-2026
To perform validation of POLE mutation by real-time PCR in a validation cohort of patients with endometroid-type EC.
Time frame: 2025-2026
To perform validation of POLE mutation by real-time PCR in a validation cohort of patients with endometroid-type EC.
Time frame: 2025-2026
To describe the overall survival of molecular types of endometroid-type EC in INCan patients.
Time frame: 2025-2026
To describe the disease-free survival of the molecular types of endometroid-type EC in INCan patients.
Contact information is provided by the study sponsor or research team.
National Institute of Cancerología
Other Gov
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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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