Brief Title
Research on the Environment and Children's Health: Retinoblastoma
Official Title
Research on the Environment and Children's Health: Retinoblastoma
Brief Summary
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.
Detailed Description
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.
Study Type
Observational
Primary Outcome
demographic and exposure information by telephone interview
Condition
Retinoblastoma
Study Arms / Comparison Groups
1
Description: Cases: retinoblastoma patients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
78
Start Date
August 2003
Completion Date
June 2008
Primary Completion Date
June 2008
Eligibility Criteria
Inclusion Criteria: - Cases will be children with sporadic heritable RBL, i.e., bilateral RBL without a family history of the disorder. - Cases will be diagnosed with retinoblastoma in an approximately 7-year period, beginning January 1, 1998 and continuing until the sample size is reached. - The case family must reside in the continental U.S., Alaska, or Canada. - The case family must have a telephone in the household. - The patient's physician must give permission to contact the parents of the case. - The biologic father or mother of the case must be available and consent to be interviewed. - The father or mother must speak English or Spanish. - Genetic counseling regarding RB1 gene mutation analysis must be done prior to registration onto study. Exclusion Criteria: - Cases that do not meet the above criteria will be ineligible to participate and excluded from the study.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Ira Dunkel, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00582049
Organization ID
03-030
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
University of Pennsylvania
Study Sponsor
Ira Dunkel, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
June 2008