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| Sponsor: | University of Puerto Rico |
|---|---|
| Collaborators: |
University of Puerto Rico Comprehensive Cancer Center National Cancer Institute (NCI) University of Southern California |
| Information provided by: | University of Puerto Rico |
| ClinicalTrials.gov Identifier: | NCT00927680 |
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: | Family-Based, Prospective |
| Official Title: | Familial Colorectal Cancer In Puerto Rico: A Feasibility Study |
Tumor blocks (colorectal tumors) and blood samples
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2007 |
| Groups/Cohorts |
|---|
| CRC cases with family history of CRC |
| CRC cases without family history of CRC |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Probands will be ascertained from the Puerto Rico Central Cancer Registry (PRCCR), from the monthly report of incident colorectal cancer cases that will be provide by Dr. Nayda Figueroa, co-investigator in this pilot project. We will follow a passive consent approval from probands identified through the PRCCC. The PRCCR allows patient contact after written notification with the probands physician in record. Physicians are notified about the intent of the investigator to contact his/her patient unless physician denies access to the patient. If the physician does not deny access to contact his/her patient, a letter will be sent to the probands informing them about the study and inviting them to contact the primary investigator.
Inclusion criteria:
Contacts and Locations| Contact: Marcia R. Cruz-Correa, MD, PhD | 787-766-1240 | marcia.cruz1@upr.edu |
| Contact: Yaritza Diaz-Algorri, MS | 787-766-1240 | yaritza.diaz7@upr.edu |
| Puerto Rico | |
| University of Puerto Rico Comprehensive Cancer Center | Recruiting |
| San Juan, Puerto Rico, 00936 | |
| Contact: Marcia R. Cruz-Correa, MD, PhD 787-766-1240 marcia.cruz1@upr.edu | |
| Contact: Yaritza Diaz-Algorri, MS 787-766-1240 yaritza.diaz7@upr.edu | |
| Principal Investigator: Marcia R. Cruz-Correa, MD, PhD | |
| Sub-Investigator: Reynold Lopez-Enriquez, MD | |
| Sub-Investigator: Edna M. Mora-Pinero, MD | |
| Sub-Investigator: Rafael A. Mosquera-Fernandez, MD | |
| Sub-Investigator: Carlos G. Micames-Caceres, MD | |
| Sub-Investigator: Nayda Figueroa-Valles, MD | |
| Principal Investigator: | Marcia R. Cruz-Correa, MD, PhD | University of Puerto Rico Comprehensive Cancer Center |
| Principal Investigator: | Robert Haile, DrPH | University of Southern California |
More Information
| Responsible Party: | University of Puerto Rico Comprehensive Cancer Center ( Marcia R. Cruz-Correa, MD, PhD ) |
| Study ID Numbers: | R03CA130034 NCI |
| Study First Received: | June 24, 2009 |
| Last Updated: | September 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00927680 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Colorectal Cancer Familial Colorectal Cancer Genetics Hispanics |
|
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
