Assessing Lynch Syndrome Frequency in Colorectal Cancer Patients
Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer
This study is trying to find out how common Lynch syndrome is in people with colorectal cancer in Russia by looking at their blood and tumor samples over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | State Scientific Centre of Coloproctology, Russian Federation Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05495776 on ClinicalTrials.gov |
What this trial studies
This observational multicenter registry study aims to evaluate the frequency of Lynch syndrome among patients diagnosed with colorectal cancer in Russia. Blood and tumor samples will be collected from participants, with microsatellite instability assessed through various methods available at the participating centers. The study will follow patients for five years to correlate genetic mutations with clinical data, treatment effectiveness, and familial cancer patterns. The goal is to enhance understanding of Lynch syndrome's impact on treatment strategies in the Russian context.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically verified colon adenocarcinoma or synchronous neoplasms who have not received prior treatment for a second tumor.
Not a fit: Patients currently undergoing chemotherapy or radiotherapy for colon cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of Lynch syndrome in colorectal cancer patients, potentially enhancing treatment outcomes.
How similar studies have performed: While similar studies have been conducted, this specific multicenter registry approach focusing on Lynch syndrome frequency in colorectal cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of written informed consent; * Patients with histologically verified colon adenocarcinoma or patients with histologically verified synchronous neoplasms who have not previously received treatment for a second tumor; * Age ≥ 18 years; * Absence of antitumor treatment for a real tumor (it is allowed to include patients who have a history of antitumor treatment for other malignant tumors, if the period after treatment is more than 12 months). * The ability of the patient, according to the Researcher, to fulfill the requirements of the Protocol; Exclusion Criteria: \- Patients receiving chemotherapy or radiotherapy for colon cancer at the time of screening
Where this trial is running
Moscow
- State Scientific Centre of Coloproctology — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Alexey Tsukanov, PhD — Head of the Department of Laboratory Genetics
- Study coordinator: Dmitrii Semenov, PhD
- Email: dr.semenov@inbox.ru
- Phone: +7 (985) 2632870
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.