Epidemiological and Molecular Colorectal Cancer Registry (EMR-CRC)

March 4, 2024 updated by: Carlos Vaccaro, Hospital Italiano de Buenos Aires
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • Caba, Buenos Aires, Argentina
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • HIBA
          • Phone Number: 8863 54-11-49590200
        • Principal Investigator:
          • Carlos Vaccaro, MD
        • Sub-Investigator:
          • María L González, MD
        • Sub-Investigator:
          • Tamara A Piñero, PhD
        • Sub-Investigator:
          • Walter H Pavicic, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing colorectal surgery due to colorectal cancer.

Description

Inclusion Criteria:

  • Adult patients undergoing colorectal surgery for colorectal cancer.

Exclusion Criteria:

  • Unwillingness to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Molecular characteristics of colorectal adenocarcinoma.
At initial diagnosis, molecular tumor markers will be determined in the tissue samples.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: Carlos Vaccaro, MD, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimated)

May 24, 2016

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1513
  • REM-CCR (Registry Identifier: Epidemiological and Molecular Colorectal Cancer Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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