Research on the Environment and Children's Health: Retinoblastoma

NCT00582049 | Completed

• 1 other identifier: 03-030
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinoblastoma

Keywords

Retinoblastoma; Sporadic heritable retinoblastoma; Paternal exposures

Outcome Measures

Primary Outcomes (1)

• demographic and exposure information by telephone interview

  5 years 4 months

Study Arms (2)

1

Cases: retinoblastoma patients

2

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects (cases) will be children with sporadic heritable RBL and their parents. Parents of children without RBL will be identified and will participate as controls.

You may qualify if:

• 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.

You may not qualify if:

• \- Cases that do not meet the above criteria will be ineligible to participate and excluded from the study.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of Pennsylvania: collaborator
• New York Presbyterian Hospital: collaborator
• Milton S. Hershey Medical Center: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Study Officials

• Ira Dunkel, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: August 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 4, 2008

Record last verified: 2008-06

Locations

US (1)