Patterns of genomic instability in gastric cancer: clinical implications and perspectives.
L Ottini, M Falchetti, R Lupi...
https://pubmed.ncbi.nlm.nih.gov/16760303Actively Recruiting
Age: 18Years +
All Genders
ID06982768
Epigenetic Mechanisms Bridging Research and Clinical Examination in hMLH1 Hypermethylated Gastric Cancer
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-01-02
245
Participants Needed
1
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
This research investigates the connection between DNA methylation and gastric cancer, focusing on the hMLH1 gene promoter hypermethylation. This epigenetic change is linked to a subtype of gastric cancer with high microsatellite instability (MSI-H) and may influence tumor behavior, resistance to chemotherapy, and immune response. The study aims to explore how hMLH1 hypermethylation relates to patient characteristics, environmental factors, and cancer treatment response. Participants in this observational study include patients who have undergone elective gastrectomy for stage I-IV gastric cancer. The study compares patients with altered expression of mismatch repair (MMR) complex components to those without such alterations. Data will be collected retrospectively from surgeries performed between January 2017 and August 2023, focusing on immunohistochemistry evaluations of MMR proteins (MLH1, PMS2, MSH2, and MSH6). During the study, researchers will analyze clinicopathologic features and environmental habits to understand their association with hMLH1 hypermethylation. The main outcome is the correlation between hMLH1-methylated gastric cancer occurrence and patient characteristics over about one year. Secondary outcomes include developing a predictive tool to classify patients based on these findings. This study involves no experimental treatments, focusing on data analysis to inform future prevention and treatment strategies.
CONDITIONS
Brief Title
How Epigenetic Changes in hMLH1 Connect Lab Research With Diagnosis in Gastric Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients who underwent elective gastrectomy for Stage I-IV gastric cancer.
- Surgery performed at the General Surgery Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS.
- Procedures conducted between January 2017 and August 2023.
- Only patients who have already undergone immunohistochemistry evaluation for expression of the components of the MMR complex (MLH1, PMS2, MSH2, and MSH6).
You will not qualify if you...
- Patients with missing immunohistochemistry evaluation for the expression of the components of the MMR complex (MLH1, PMS2, MSH2, and MSH6).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Based on prior surgery between January 2017 and August 2023
Participants undergo immunohistochemistry evaluation to assess the expression of the components of the MMR complex.
Long-term Monitoring
Duration - Approximately 1 year
Participants are observed to correlate hMLH1 hypermethylated gastric cancer with clinical and pathological characteristics over approximately one year.
Trial Site Locations
Total: 1 location
1
UOC Chirurgia Generale 1 - Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
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Research Team
A
Annamaria Agnes
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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