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

Colorectal Cancer Clinical Trial

— MSIRus22  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495776
• Other study ID #: 01082022
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2022
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: Dmitrii Semenov, PhD
• Phone: +7 (985) 2632870
• Email: dr.semenov[@]inbox.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective multicenter registry study to assess the frequency of Lynch syndrome among patients with colorectal cancer in Russia

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2028
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hereditary Colorectal Cancer
• Lynch Syndrome
• MSI
• Syndrome

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (9)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation	Botkin Hospital MHD, City Clinical Oncological Hospital No. 1 MHD, Clinic K+31, D.D. Pletnev City Clinical Hospital MHD, MMCC Kommunarka MHD, Moscow City Oncological Hospital No. 62 MHD, Pirogov National Medical and Surgical Center, The Loginov MCSC MHD

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of occurrence of microsatellite instability/deficiency	Assessment of the frequency of occurrence of microsatellite instability/deficiency in the repair system of unpaired bases in second tumors in patients with colorectal cancer of various stages.	up to 5 years
Secondary	Spectrum of germinal mutations in Lynch syndrome	The mlh1, msh2, msh6, pms2 and epcam genes will be examined for the presence of all types of pathogenic variants in patients with MSI in colon tumor. The possible correlation of gene-phenotype and pathogenic variants of each gene-phenotype will also be studied. To detect MSI in a tumor sample, need to do the fragment analysis (markers NR21, NR24, NR27, BAT25, BAT26). ?atients with MSI in the tumor will have DNA diagnostics of MMR EPCAM genes by sequencing and MLPA . The MMR and EPCAM genes will be examined in DNA isolated from blood lymphocytes.	up to 5 years
Secondary	Spectrum of malignant neoplasms	The family history of all oncological diseases will be studied to find out the main target organs of patients with Lynch syndrome in Russia	up to 5 years
Secondary	Effectiveness of therapy with immune checkpoint inhibitors	The frequency will be compared: the frequency of objective response rate (RECIST 1.1) while using immune checkpoint inhibitors in metastatic colon cancer and microsatellite instability associated/not associated with Lynch syndrome	up to 5 years
Secondary	Impact of the presence of microsatellite instability/deficiency	The frequency of adjuvant chemotherapy in stages II-III of colon cancer in the presence of microsatellite instability / deficiency in the repair system of unpaired bases in real clinical practice will be evaluated	up to 5 years