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Research on the Environment and Children's Health: Retinoblastoma

NCT ID: NCT00582049

Last Updated: 2008-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Retinoblastoma

Keywords

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Retinoblastoma Sporadic heritable retinoblastoma Paternal exposures

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Cases: retinoblastoma patients

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

New York Presbyterian Hospital

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Memorial Sloan-Kettering Cancer Center

Principal Investigators

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Ira Dunkel, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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03-030

Identifier Type: -

Identifier Source: org_study_id