Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer
MSIRus22
1 other identifier
observational
2,500
1 country
1
Brief Summary
Prospective multicenter registry study to assess the frequency of Lynch syndrome among patients with colorectal cancer in Russia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedFirst Posted
Study publicly available on registry
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedOctober 25, 2022
August 1, 2022
3 years
July 29, 2022
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of microsatellite instability and Lynch syndrome
To assess the frequency of microsatellite instability and Lynch syndrome in the population of patients with colorectal cancer in the Russian Federation.
up to 5 years
Secondary Outcomes (5)
Frequency of occurrence of microsatellite instability/deficiency
up to 5 years
Spectrum of germinal mutations in Lynch syndrome
up to 5 years
Spectrum of malignant neoplasms
up to 5 years
Effectiveness of therapy with immune checkpoint inhibitors
up to 5 years
Impact of the presence of microsatellite instability/deficiency
up to 5 years
Study Arms (1)
Patients with colorectal cancer
Patients with colon adenocarcinoma who have not previously received antitumor treatment (chemo/radiation therapy) for a currently detected tumor
Eligibility Criteria
Patients with colon adenocarcinoma who have not previously received antitumor treatment (chemo/radiation therapy) for a currently detected tumor
You may qualify if:
- 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;
You may not qualify if:
- \- Patients receiving chemotherapy or radiotherapy for colon cancer at the time of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- State Scientific Centre of Coloproctology, Russian Federationlead
- The Loginov MCSC MHDcollaborator
- Pirogov National Medical and Surgical Centercollaborator
- Moscow City Oncological Hospital No. 62 MHDcollaborator
- City Clinical Oncological Hospital No. 1 MHDcollaborator
- MMCC Kommunarka MHDcollaborator
- D.D. Pletnev City Clinical Hospital MHDcollaborator
- Botkin Hospital MHDcollaborator
- Clinic K+31collaborator
Study Sites (1)
State Scientific Centre of Coloproctology
Moscow, 123423, Russia
Biospecimen
In case of microsatellite instability/deficiency in the repair system of unpaired bases, venous blood will be taken 4 ml into a test tube with EDTA with freezing at -20 \* C
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexey Tsukanov, PhD
Head of the Department of Laboratory Genetics
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2022
First Posted
August 10, 2022
Study Start
August 1, 2022
Primary Completion
August 1, 2025
Study Completion (Estimated)
December 31, 2028
Last Updated
October 25, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- 6 months after completion of the study
- Access Criteria
- upon the request
Before the start of the study, at the initiating visit, the monitor, together with the researchers and their staff, will review the protocol and the CRF. During the study, the monitor will regularly communicate remotely with the research center and check the process of inclusion of patients, the completeness of maintaining medical records of patients, the correctness of filling out the CRF. The researcher must provide the monitor with access to the relevant hospital documentation and other medical records to verify their compliance with the data recorded in the IRC. The data identifying the patient's identity will remain confidential.