Research on the Environment and Children's Health: Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Research on the Environment and Children's Health: Retinoblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582049
• Other study ID #: 03-030
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: July 3, 2008
• Start date: August 2003
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Retinoblastoma

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Milton S. Hershey Medical Center, New York Presbyterian Hospital, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	demographic and exposure information by telephone interview		5 years 4 months	No

External Links

•   Memorial Sloan-Kettering Cancer Center