Investigating the link between hMLH1 gene changes and gastric cancer diagnosis
Epigenetic Mechanisms Bridging Research and Clinical Examination in hMLH1 Hypermethylated Gastric Cancer
This study is testing how changes in a specific gene might help doctors better understand and diagnose gastric cancer in patients who have had surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 245 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT06982768 on ClinicalTrials.gov |
What this trial studies
This observational study examines the role of epigenetic changes, specifically DNA methylation of the hMLH1 gene, in gastric cancer patients who have undergone gastrectomy. It focuses on understanding how these changes correlate with different molecular phenotypes of gastric cancer, particularly those characterized by microsatellite instability (MSI-H). The study includes patients who have had immunohistochemistry evaluations for the mismatch repair (MMR) complex components. By analyzing these epigenetic markers, the research aims to enhance diagnostic accuracy and treatment strategies for gastric cancer.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone elective gastrectomy for Stage I-IV gastric cancer and have had prior immunohistochemistry evaluations.
Not a fit: Patients without immunohistochemistry evaluations for the MMR complex components will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnosis and treatment of gastric cancer by linking epigenetic changes to clinical outcomes.
How similar studies have performed: While the specific approach of linking hMLH1 methylation to gastric cancer diagnosis is novel, similar studies have shown promise in understanding epigenetic factors in cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: \- Patients with missing immunohistochemistry evaluation for the expression of the components of the MMR complex (MLH1, PMS2, MSH2, and MSH6).
Where this trial is running
Rome
- UOC Chirurgia Generale 1 - Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Annamaria Agnes — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Annamaria Agnes
- Email: annamaria.agnes@policlinicogemelli.it
- Phone: +39 0630167190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.