Epidemiological and Molecular Colorectal Cancer Registry (EMR-CRC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02781337|
Recruitment Status : Recruiting
First Posted : May 24, 2016
Last Update Posted : January 17, 2019
|Condition or disease|
|Colorectal Neoplasms Colorectal Cancer|
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|
|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|
- Overall survival [ Time Frame: 5 years ]Patient overall survival at 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.
- 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
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
|Contact: Carlos Vaccaro, MDemail@example.com|
|Contact: María L González, MDfirstname.lastname@example.org|
|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|
|Principal Investigator:||Carlos Vaccaro, MD||Hospital Italiano de Buenos Aires|