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Epidemiological and Molecular Colorectal Cancer Registry (EMR-CRC)

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ClinicalTrials.gov Identifier: NCT02781337
Recruitment Status : Recruiting
First Posted : May 24, 2016
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos Vaccaro, 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.

Condition or disease
Colorectal Neoplasms Colorectal Cancer

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 [Patient Registry]
Estimated Enrollment : 1447 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Epidemiological and Molecular Colorectal Cancer Registry
Study Start Date : May 2012
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2033

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Patient overall survival at 5 years.

  2. 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.


Secondary Outcome Measures :
  1. Molecular characteristics of colorectal adenocarcinoma. [ Time Frame: 0 ]
    At initial diagnosis, molecular tumor markers will be determined in the tissue samples.


Biospecimen Retention:   Samples With DNA
Tissue samples and blood specimens are frozen and store at Eighty degrees below 0 degrees Celsius (-80ºC).


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 96 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing colorectal surgery due to colorectal cancer.
Criteria

Inclusion Criteria:

  • Adult patients undergoing colorectal surgery for colorectal cancer.

Exclusion Criteria:

  • Unwillingness to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781337


Contacts
Contact: Carlos Vaccaro, MD carlos.vaccaro@hospitalitaliano.org.ar
Contact: María L González, MD marialaura.gonzalez@hospitalitaliano.org.ar

Locations
Argentina
Hospital Italiano de Buenos Aires Recruiting
Caba, Buenos Aires, Argentina
Contact: HIBA    54-11-49590200 ext 8863      
Principal Investigator: Carlos Vaccaro, MD         
Sub-Investigator: María L González, MD         
Sub-Investigator: Tamara A Piñero, PhD         
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
Principal Investigator: Carlos Vaccaro, MD Hospital Italiano de Buenos Aires

Publications:

Responsible Party: Carlos Vaccaro, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02781337     History of Changes
Other Study ID Numbers: 1513
REM-CCR ( Registry Identifier: Epidemiological and Molecular Colorectal Cancer Registry )
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases