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Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer

NCT05495776 · State Scientific Centre of Coloproctology, Russian Federation
In plain English

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About this study
Blood and tumor samples will be obtained from enrolled patients. 4 ml of venous blood samples will be taken into a tube with EDTA and stored at -20 0C. Tumor samples will be taken during endoscopy or surgical treatment, embedded in paraffin and stored at room temperature. Microsatellite instability in the tumor tissue will be determined by any method available in the participating center (immunohistochemical or molecular genetic study). In case of detection of microsatellite instability/deficiency in the repair system of unpaired bases blood samples will be analyzed for the fact that germinal mutations in the DNA mismatch repair genes. Patients will be followed up for 5 years after enrollment. During follow up correlation of spectrum of germinal mutations with clinical data, effectiveness of therapy with immune checkpoint inhibitors, the spectrum of malignant neoplasms in the families of patients with Lynch syndrome, the impact of the presence of microsatellite instability/deficiency in the DNA mismatch repair genes on treatment tactics in the Russian Federation will be assessed.
Eligibility 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
Study design
Enrollment target: 2500 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-08-01
Estimated completion: 2028-12-31
Last updated: 2022-10-25
Primary outcomes
  • Frequency of microsatellite instability and Lynch syndrome (up to 5 years)
Sponsor
State Scientific Centre of Coloproctology, Russian Federation · other_gov
With: The Loginov MCSC MHD, Pirogov National Medical and Surgical Center, Moscow City Oncological Hospital No. 62 MHD, City Clinical Oncological Hospital No. 1 MHD, MMCC Kommunarka MHD, D.D. Pletnev City Clinical Hospital MHD, Botkin Hospital MHD, Clinic K+31
Contacts & investigators
ContactDmitrii Semenov, PhD · contact · dr.semenov@inbox.ru · +7 (985) 2632870
ContactAlexey Tsukanov, PhD · contact · tsukanov81@rambler.ru · +7 (916) 7563957
InvestigatorAlexey Tsukanov, PhD · principal_investigator, Head of the Department of Laboratory Genetics
All locations (1)
State Scientific Centre of ColoproctologyRecruiting
Moscow, Russia
Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer · TrialPath