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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