Viewing Study NCT06206083



Ignite Creation Date: 2024-05-06 @ 7:59 PM
Last Modification Date: 2024-10-26 @ 3:18 PM
Study NCT ID: NCT06206083
Status: RECRUITING
Last Update Posted: 2024-02-28
First Post: 2023-12-05

Brief Title: Molecular Classification in Mexican Patients With Endometrial Cancer and Its Impact on Prognosis
Sponsor: National Institute of Cancerología
Organization: National Institute of Cancerología

Study Overview

Official Title: Molecular Classification in Mexican Patients With Endometrial Cancer and Its Impact on Prognosis
Status: RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 N32 and the detection of POLE mutations DNA will be extracted using the DNARNA 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 Illuminas 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None