Epidemiological and Molecular Colorectal Cancer Registry

NCT02781337 | Recruiting

• 2 other identifiers: 1513REM-CCR
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Patient overall survival at 5 years.

  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.

  5 years

Secondary Outcomes (1)

• Molecular characteristics of colorectal adenocarcinoma.

  0

Eligibility Criteria

• Age: 21 Years - 96 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing colorectal surgery due to colorectal cancer.

You may qualify if:

• Adult patients undergoing colorectal surgery for colorectal cancer.

You may not qualify if:

• Unwillingness to participate.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

CABA, Buenos Aires, Argentina

RECRUITING

Related Publications (8)

• 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.

  PMID: 24512910 BACKGROUND

• Kim 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.

  PMID: 24764661 BACKGROUND

• Phipps 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.

  PMID: 25280443 BACKGROUND

• Kim 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.

  PMID: 26148739 BACKGROUND

• Jenkins 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.

  PMID: 17631130 BACKGROUND

• Webber 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.

  PMID: 25884995 BACKGROUND

• Park 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.

  PMID: 16740762 BACKGROUND

• Jass 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.

  PMID: 17204026 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples and blood specimens are frozen and store at Eighty degrees below 0 degrees Celsius (-80ºC).

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Carlos Vaccaro, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Vaccaro, MD

CONTACT

carlos.vaccaro@hospitalitaliano.org.ar

María L González, MD

CONTACT

marialaura.gonzalez@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 24, 2016
• Study Start: May 1, 2012
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2033
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

AR (1)