Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Lynch Syndrome, Hereditary Colorectal Cancer, MSI. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Prospective multicenter registry study to assess the frequency of Lynch syndrome among patients with colorectal cancer in Russia
Detailed description
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.
Primary outcome measures
- Frequency of microsatellite instability and Lynch syndrome [Time frame: up to 5 years]
Secondary outcome measures (5)
- Frequency of occurrence of microsatellite instability/deficiency [Time frame: up to 5 years]
- Spectrum of germinal mutations in Lynch syndrome [Time frame: up to 5 years]
- Spectrum of malignant neoplasms [Time frame: up to 5 years]
- Effectiveness of therapy with immune checkpoint inhibitors [Time frame: up to 5 years]
- Impact of the presence of microsatellite instability/deficiency [Time frame: up to 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- State Scientific Centre of Coloproctology — Moscow
Identifiers
NCT: NCT05495776 · 01082022