Research on the Environment and Children's Health: Retinoblastoma
The purpose of the research study is to learn more about the causes of retinoblastoma and to identify possible risk factors in the parents of patients with retinoblastoma. This kind of study is called an epidemiology study and is often done by interviewing people with and without the disease. In the case of a childhood disease, the researchers ask about experiences of the parents and children before the disease developed.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Research on the Environment and Children's Health: Retinoblastoma|
- demographic and exposure information by telephone interview [ Time Frame: 5 years 4 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||August 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Cases: retinoblastoma patients
Controls: first cousins or other blood relatives of the retinoblastoma patients (relative controls) or friends of the retinoblastoma patients or children of friends of the parents (friend controls).
The purpose of the study is to investigate the role of paternal exposures in the etiology of sporadic heritable retinoblastoma (RBL). The study has a matched case-control design with a sample size of 255 pairs. Cases will be children with sporadic heritable (RBL) identified from eight hospitals that together treat most of the RBL patients in the U.S. and Canada. We will use regional controls matched on year of birth and state/province of residence identified by randomdigit-dialing (RDD). Fathers and mothers of cases and controls will be interviewed by telephone about their occupational, medical, dietary, and personal exposures before the index child's conception. Blood samples will be obtained on cases and their parents for DNA isolation. The case's DNA will be used to characterize the disease-causing RB1 mutation. The parent's DNA will be used to detect the few instances in which a parent also has the RB1 mutation, i.e., the child's RBL is familial rather than sporadic.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582049
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Ira Dunkel, MD||Memorial Sloan-Kettering Cancer Center|