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

NCT ID: NCT05495776

Condition: Colorectal Cancer
Lynch Syndrome
Hereditary Colorectal Cancer
MSI

Conditions: Official terms:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Syndrome

Conditions: Keywords:
Colorectal Cancer
Lynch Syndrome
Hereditary Colorectal Cancer
MSI
Frequency

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Summary: 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.

Criteria for eligibility:

Study pop:
Patients with colon adenocarcinoma who have not previously received antitumor treatment (chemo/radiation therapy) for a currently detected tumor

Sampling method: Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: State Scientific Centre of Coloproctology

Address:
City: Moscow
Zip: 123423
Country: Russian Federation

Status: Recruiting

Contact:
Last name: Alexey Tsukanov, Phd

Phone: +79167563957
Email: tsukanov81@rambler.ru

Start date: August 1, 2022

Completion date: December 31, 2028

Lead sponsor:
Agency: State Scientific Centre of Coloproctology, Russian Federation
Agency class: Other

Collaborator:
Agency: The Loginov MCSC MHD
Agency class: Other

Collaborator:
Agency: Pirogov National Medical and Surgical Center
Agency class: Other

Collaborator:
Agency: Moscow City Oncological Hospital No. 62 MHD
Agency class: Other

Collaborator:
Agency: City Clinical Oncological Hospital No. 1 MHD
Agency class: Other

Collaborator:
Agency: MMCC Kommunarka MHD
Agency class: Other

Collaborator:
Agency: D.D. Pletnev City Clinical Hospital MHD
Agency class: Other

Collaborator:
Agency: Botkin Hospital MHD
Agency class: Other

Collaborator:
Agency: Clinic K+31
Agency class: Other

Source: State Scientific Centre of Coloproctology, Russian Federation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05495776

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