Familial Colorectal Cancer Registry in Hispanics (PURIFICAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Puerto Rico
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marcia R. Cruz-Correa, MD, PhD, University of Puerto Rico
ClinicalTrials.gov Identifier:
NCT00927680
First received: June 24, 2009
Last updated: December 3, 2014
Last verified: December 2014
  Purpose

Colorectal cancer (CRC) is the second leading cause of cancer in Puerto Rico (PR) accounting for approximately 1,500 individuals annually, which represent 12% of all cancer cases in the island. The genetic epidemiology of CRC among Hispanic populations is not well studied, hence studies focused on large, well defined ethnic groups such as Puerto Ricans, are clearly warranted. The first step towards evaluating the molecular, environmental, and genetic epidemiology of CRC in PR is to establish a population-based familial CRC registry. The following specific aims have been proposed:

Specific Aim 1: To prospectively identify and recruit approximately 300 CRC probands from two distinct geographical areas in PR (Metropolitan and Southern Region). From each proband the investigators will obtain a pedigree extended to second-degree relatives and cousins. Assuming 10% will be positive for a family history of CRC, the investigators will then recruit all 30 probands with a family history of CRC and a sample of 15 family-history negative probands and obtain: paraffin-embedded tumors blocks, blood samples, risk factor and food frequency questionnaires.

Specific Aim 2: To prospectively identify and recruit selected relatives (parents, grandparents, and same generation relatives - cousins and siblings) from the 45 probands identified in Specific Aim 1. In addition, for siblings and cousins of probands (i.e. relatives in the same generation as the proband), the investigators will obtain risk factor and food frequency questionnaires, and for colorectal cancer cases, tumor blocks and pathology reports of their cancers.

Specific Aim 3: To estimate from this pilot study the following parameters: (a) response rate of probands and their selected relatives; (b) response rate of participants for each data item; (c) family history of CRC and other cancers; (d) number of living first- and second-degree relatives and cousins of probands; (e) number of these relatives who live in the same household and region/municipality; (f) prevalence/distribution of selected risk factors from the administered questionnaires.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Familial Colorectal Cancer In Puerto Rico: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of Puerto Rico:

Primary Outcome Measures:
  • We will recruit individuals with colorectal cancer with and without family history of CRC and their immediate family members and obtain the following: paraffin-embedded tumors blocks, blood samples, risk factor and food frequency questionnaires. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • We will study the following parameters that we help us plan the larger population-based study such as: response rate of probands and their selected relatives, response rate of participants (probands and relatives), etcetera. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor blocks (colorectal tumors) and blood samples


Estimated Enrollment: 5000
Study Start Date: July 2007
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Colorectal cancer cases
Controls

Detailed Description:

Data obtained from this study will serve as the foundation for our large, island-wide, population-based, genetic-epidemiologic study of familial colorectal cancer in Puerto Rico. Through this feasibility study, we will assess the feasibility: (1) of recruiting colorectal cancer patients using the PR Central Cancer Registry, (2) of evaluating family pedigrees and recruiting the relatives of probands (3) obtaining tumor, blood, medical and exposure information from both probands and their relatives. Providing important data on Hispanic populations that would enable family-based case-control studies of risk factors for CRC, with an emphasis on candidate genes in selected carcinogenic pathways, genetic and epigenetic modifications. Furthermore, information obtained from this proposal may serve to identify families that would be informative for linkage studies to potentially map new genes, evaluate genotype-phenotype correlations, gene-gene and gene-environmental interactions.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Probands will be ascertained from the Puerto Rico Central Cancer Registry (PRCCR), from the monthly report of incident colorectal cancer cases. Eligible cases were persons (1) with pathologic diagnosis of colorectal cancer; (2) who were 15 years of age or older, and (3) without previous history of colorectal cancer.
  2. Probands will be ascertained from the Oncology Hospital, UDH Hospital and the Ashford Presbyterian Community Hospital.
Criteria

Inclusion criteria:

  • patients with colon polyps or colon cancer
  • patients will have a colonoscopy or colon surgery to treat a benign condition such as fissure, fistula, or hemorrhoids

Exclusion criteria:

Participation in this study is limited to persons 15 years or older with colon polyps or colon cancer and control subjects 21 years or older with no malignant conditions in the colon and / or rectum. Controls between the ages of 15 to 20 years will be not evaluated. The reason is colon cancer occurs in people under 21 years, except in special cases associated with certain genetic causes. People who cannot sign the consent may not participate in this study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927680

Contacts
Contact: Marcia R. Cruz-Correa, MD, PhD 787-772-8300 ext 1221 marcia.cruz1@upr.edu
Contact: Yaritza Diaz-Algorri, MS, DrPH 787-772-8300 ext 1221 yaritza.diaz7@upr.edu

Locations
Puerto Rico
University of Puerto Rico Comprehensive Cancer Center Recruiting
San Juan, Puerto Rico, 00936
Contact: Marcia R. Cruz-Correa, MD, PhD    787-772-8300 ext 1221    marcia.cruz1@upr.edu   
Contact: Yaritza Diaz-Algorri, MS, DrPH    787-772-8300 ext 1221    yaritza.diaz7@upr.edu   
Principal Investigator: Marcia R. Cruz-Correa, MD, PhD         
Sub-Investigator: Reynold Lopez-Enriquez, MD         
Sub-Investigator: Rafael A. Mosquera-Fernandez, MD         
Sub-Investigator: Carlos G. Micames-Caceres, MD         
Sub-Investigator: Segundo Rodriguez-Quilichini, MD         
Sponsors and Collaborators
University of Puerto Rico
Investigators
Principal Investigator: Marcia R. Cruz-Correa, MD, PhD University of Puerto Rico
  More Information

No publications provided

Responsible Party: Marcia R. Cruz-Correa, MD, PhD, Associate Professor of Medicine, Biochemistry and Surgery at University of Puerto Rico School of Medicine, Director of Gastrointestinal Oncology at the University of Puerto Rico (UPR) Comprehensive Cancer Center, University of Puerto Rico
ClinicalTrials.gov Identifier: NCT00927680     History of Changes
Other Study ID Numbers: R03CA130034 NCI
Study First Received: June 24, 2009
Last Updated: December 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Puerto Rico:
Colorectal Cancer
Familial Colorectal Cancer
Genetics
Hispanics

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

ClinicalTrials.gov processed this record on July 05, 2015