Epidemiological and Molecular Colorectal Cancer Registry

Recruiting

• Conditions: Colorectal Cancer; Colorectal Neoplasms

• Registration Number: NCT02781337
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

This is a Registry that invites patients undergoing colorectal surgery for colorectal cancer. Epidemiological data is collected. The Registry includes tumor tissue and blood banks for analyzing different genetic mutations and disease-specific biomarkers.

Detailed Description

This is a Registry that invites patients undergoing colorectal surgery for colorectal cancer. Epidemiological data is collected. The Registry includes tumor tissue and blood samples banks used to studied different genetic variants and disease-specific biomarkers present in patients with Lynch syndrome and others hereditary cancers.

The aim of this registry is to set up the necessary resources to help basic and clinical research projects on colorectal cancer (CRC) within the Hospital Italiano de Buenos Aires (HIBA) and promote scientific collaborations between the HIBA and other institutions within and outside the country.

To make this project, the following specific goals are proposed:

Objective 1: Establishment of an efficient algorithm to enroll patients diagnosed with CRC from HIBA, through collaboration between the services of Surgery, Gastroenterology, Pathology, Oncology, Institute of Translational Medicine and Biomedical Engineering (IMTIB), Medical Clinic and Medical Informatics.

Objective 2: Development of logistics for the connection and expansion of the bank of biological samples (DNA, serum) and tumor samples (tissue fixed in formalin, frozen tissue) to the CRC.

Objective 3: Development of computer software to record data about patient enrolled in a dynamic way.

Objective 4: Development of pipelines and create a supervisory committee to regulate the future of samples and data obtained through the registry, accord the current standards of ethical code, and improve the current collaborations with foreign researchers.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2027-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

• Adult patients undergoing colorectal surgery for colorectal cancer.

Exclusion Criteria

• Unwillingness to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival	5 years	The time free of disease recurrence will be estimated in the whole cohort and according to colorectal cancer stages and molecular profiles.
Overall survival	5 years	Patient overall survival at 5 years.

Secondary Outcome Measures

Name	Time	Method
Molecular characteristics of colorectal adenocarcinoma.	0	At initial diagnosis, molecular tumor markers will be determined in the tissue samples.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Caba, Buenos Aires, Argentina