Colorectal NeoplasmsEMR-CRCNCT02781337
Epidemiological and Molecular Colorectal Cancer Registry
An observational study of Colorectal Neoplasms and Colorectal Cancer, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 96 years
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Cancer
- How many people
- 2,100 participants
- Where
- 1 siteArgentina
- Study dates
- May 2012to Dec 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 96 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing colorectal surgery due to colorectal cancer.
Who may be able to join
- Adult patients undergoing colorectal surgery for colorectal cancer.
Who cannot join
- Unwillingness to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carlos Vaccaro, MD contact
María L González, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
CABA, Buenos Aires
HIBA, 54-11-49590200 ext. 8863
Carlos Vaccaro, MD
About this study
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.
Read the 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.
- Conditions
- Colorectal Neoplasms, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Patient overall survival at 5 years.
Measured: 5 years
Disease-free survival
The time free of disease recurrence will be estimated in the whole cohort and according to colorectal cancer stages and molecular profiles.
Measured: 5 years
Secondary outcomes (1)
Molecular characteristics of colorectal adenocarcinoma.
At initial diagnosis, molecular tumor markers will be determined in the tissue samples.
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startMay 2012
- Primary completionDec 2029 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,100 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Vaccaro, Hospital Italiano de Buenos Aires
- Investigators
- Carlos Vaccaro, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781337
- Sponsor's protocol ID
- 1513
- Other IDs
- REM-CCR
- Acronym
- EMR-CRC
- Status last verified
- Apr 2026
- First submitted
- 17 May 2016
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Collura A, Lagrange A, Svrcek M, Marisa L, Buhard O, Guilloux A, Wanherdrick K, Dorard C, Taieb A, Saget A, Loh M, Soong R, Zeps N, Platell C, Mews A, Iacopetta B, De Thonel A, Seigneuric R, Marcion G, Chapusot C, Lepage C, Bouvier AM, Gaub MP, Milano G, Selves J, Senet P, Delarue P, Arzouk H, Lacoste C, Coquelle A, Bengrine-Lefevre L, Tournigand C, Lefevre JH, Parc Y, Biard DS, Flejou JF, Garrido C, Duval A. Patients with colorectal tumors with microsatellite instability and large deletions in HSP110 T17 have improved response to 5-fluorouracil-based chemotherapy. Gastroenterology. 2014 Feb;146(2):401-11.e1. doi: 10.1053/j.gastro.2013.10.054.
PubMed 24512910Kim JH, Kang GH. Molecular and prognostic heterogeneity of microsatellite-unstable colorectal cancer. World J Gastroenterol. 2014 Apr 21;20(15):4230-43. doi: 10.3748/wjg.v20.i15.4230.
PubMed 24764661Phipps AI, Limburg PJ, Baron JA, Burnett-Hartman AN, Weisenberger DJ, Laird PW, Sinicrope FA, Rosty C, Buchanan DD, Potter JD, Newcomb PA. Association between molecular subtypes of colorectal cancer and patient survival. Gastroenterology. 2015 Jan;148(1):77-87.e2. doi: 10.1053/j.gastro.2014.09.038. Epub 2014 Sep 30.
PubMed 25280443Kim JH, Bae JM, Oh HJ, Lee HS, Kang GH. Pathologic Factors Associated with Prognosis after Adjuvant Chemotherapy in Stage II/III Microsatellite-Unstable Colorectal Cancers. J Pathol Transl Med. 2015 Mar;49(2):118-28. doi: 10.4132/jptm.2015.02.05. Epub 2015 Mar 12.
PubMed 26148739Jenkins MA, Hayashi S, O'Shea AM, Burgart LJ, Smyrk TC, Shimizu D, Waring PM, Ruszkiewicz AR, Pollett AF, Redston M, Barker MA, Baron JA, Casey GR, Dowty JG, Giles GG, Limburg P, Newcomb P, Young JP, Walsh MD, Thibodeau SN, Lindor NM, Lemarchand L, Gallinger S, Haile RW, Potter JD, Hopper JL, Jass JR; Colon Cancer Family Registry. Pathology features in Bethesda guidelines predict colorectal cancer microsatellite instability: a population-based study. Gastroenterology. 2007 Jul;133(1):48-56. doi: 10.1053/j.gastro.2007.04.044. Epub 2007 Apr 25.
PubMed 17631130Webber EM, Kauffman TL, O'Connor E, Goddard KA. Systematic review of the predictive effect of MSI status in colorectal cancer patients undergoing 5FU-based chemotherapy. BMC Cancer. 2015 Mar 21;15:156. doi: 10.1186/s12885-015-1093-4.
PubMed 25884995Park JG, Kim DW, Hong CW, Nam BH, Shin YK, Hong SH, Kim IJ, Lim SB, Aronson M, Bisgaard ML, Brown GJ, Burn J, Chow E, Conrad P, Douglas F, Dunlop M, Ford J, Greenblatt MS, Heikki J, Heinimann K, Lynch EL, Macrae F, McKinnon WC, Moeslein G, Rossi BM, Rozen P, Schofield L, Vaccaro C, Vasen H, Velthuizen M, Viel A, Wijnen J; International Society for Gastrointestinal Hereditary Tumours. Germ line mutations of mismatch repair genes in hereditary nonpolyposis colorectal cancer patients with small bowel cancer: International Society for Gastrointestinal Hereditary Tumours Collaborative Study. Clin Cancer Res. 2006 Jun 1;12(11 Pt 1):3389-93. doi: 10.1158/1078-0432.CCR-05-2452.
PubMed 16740762Jass JR. Classification of colorectal cancer based on correlation of clinical, morphological and molecular features. Histopathology. 2007 Jan;50(1):113-30. doi: 10.1111/j.1365-2559.2006.02549.x.
PubMed 17204026
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological and Molecular Colorectal Cancer Registry
- ClinicalTrials.gov ID
- NCT02781337
- Acronym / sponsor ID
- EMR-CRC / 1513
- Conditions
- Colorectal Neoplasms, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 24 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 21 to 96 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colorectal surgery due to colorectal cancer.
Key inclusion criteria (1 listed)
- Adult patients undergoing colorectal surgery for colorectal cancer.
Key exclusion criteria (1 listed)
- Unwillingness to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Molecular characteristics of colorectal adenocarcinoma.
Time frame: 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 24512910Collura A, Lagrange A, Svrcek M, Marisa L, Buhard O, Guilloux A, Wanherdrick K, Dorard C, Taieb A, Saget A, Loh M, Soong R, Zeps N, Platell C, Mews A, Iacopetta B, De Thonel A, Seigneuric R, Marcion G, Chapusot C, Lepage C, Bouvier AM, Gaub MP, Milano G, Selves J, Senet P, Delarue P, Arzouk H, Lacoste C, Coquelle A, Bengrine-Lefevre L, Tournigand C, Lefevre JH, Parc Y, Biard DS, Flejou JF, Garrido C, Duval A. Patients with colorectal tumors with microsatellite instability and large deletions in HSP110 T17 have improved response to 5-fluorouracil-based chemotherapy. Gastroenterology. 2014 Feb;146(2):401-11.e1. doi: 10.1053/j.gastro.2013.10.054.
- Background: PubMed 24764661Kim JH, Kang GH. Molecular and prognostic heterogeneity of microsatellite-unstable colorectal cancer. World J Gastroenterol. 2014 Apr 21;20(15):4230-43. doi: 10.3748/wjg.v20.i15.4230.
- Background: PubMed 25280443Phipps AI, Limburg PJ, Baron JA, Burnett-Hartman AN, Weisenberger DJ, Laird PW, Sinicrope FA, Rosty C, Buchanan DD, Potter JD, Newcomb PA. Association between molecular subtypes of colorectal cancer and patient survival. Gastroenterology. 2015 Jan;148(1):77-87.e2. doi: 10.1053/j.gastro.2014.09.038. Epub 2014 Sep 30.
- Background: PubMed 26148739Kim JH, Bae JM, Oh HJ, Lee HS, Kang GH. Pathologic Factors Associated with Prognosis after Adjuvant Chemotherapy in Stage II/III Microsatellite-Unstable Colorectal Cancers. J Pathol Transl Med. 2015 Mar;49(2):118-28. doi: 10.4132/jptm.2015.02.05. Epub 2015 Mar 12.
- Background: PubMed 17631130Jenkins MA, Hayashi S, O'Shea AM, Burgart LJ, Smyrk TC, Shimizu D, Waring PM, Ruszkiewicz AR, Pollett AF, Redston M, Barker MA, Baron JA, Casey GR, Dowty JG, Giles GG, Limburg P, Newcomb P, Young JP, Walsh MD, Thibodeau SN, Lindor NM, Lemarchand L, Gallinger S, Haile RW, Potter JD, Hopper JL, Jass JR; Colon Cancer Family Registry. Pathology features in Bethesda guidelines predict colorectal cancer microsatellite instability: a population-based study. Gastroenterology. 2007 Jul;133(1):48-56. doi: 10.1053/j.gastro.2007.04.044. Epub 2007 Apr 25.
- Background: PubMed 25884995Webber EM, Kauffman TL, O'Connor E, Goddard KA. Systematic review of the predictive effect of MSI status in colorectal cancer patients undergoing 5FU-based chemotherapy. BMC Cancer. 2015 Mar 21;15:156. doi: 10.1186/s12885-015-1093-4.
- Background: PubMed 16740762Park JG, Kim DW, Hong CW, Nam BH, Shin YK, Hong SH, Kim IJ, Lim SB, Aronson M, Bisgaard ML, Brown GJ, Burn J, Chow E, Conrad P, Douglas F, Dunlop M, Ford J, Greenblatt MS, Heikki J, Heinimann K, Lynch EL, Macrae F, McKinnon WC, Moeslein G, Rossi BM, Rozen P, Schofield L, Vaccaro C, Vasen H, Velthuizen M, Viel A, Wijnen J; International Society for Gastrointestinal Hereditary Tumours. Germ line mutations of mismatch repair genes in hereditary nonpolyposis colorectal cancer patients with small bowel cancer: International Society for Gastrointestinal Hereditary Tumours Collaborative Study. Clin Cancer Res. 2006 Jun 1;12(11 Pt 1):3389-93. doi: 10.1158/1078-0432.CCR-05-2452.
- Background: PubMed 17204026Jass JR. Classification of colorectal cancer based on correlation of clinical, morphological and molecular features. Histopathology. 2007 Jan;50(1):113-30. doi: 10.1111/j.1365-2559.2006.02549.x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Vaccaro, MD contact
María L González, MD contact
Carlos Vaccaro, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Colorectal Cancer, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Vaccaro, MD (carlos.vaccaro@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781337, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.