Research on the Environment and Children’s Health: Retinoblastoma

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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