Research on the Environment and Children's Health: Retinoblastoma

This study has been completed.
Sponsor:
Collaborators:
University of Pennsylvania
New York Presbyterian Hospital
Milton S. Hershey Medical Center
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582049
First received: December 21, 2007
Last updated: July 3, 2008
Last verified: June 2008
  Purpose

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.


Condition
Retinoblastoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Research on the Environment and Children's Health: Retinoblastoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • demographic and exposure information by telephone interview [ Time Frame: 5 years 4 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 78
Study Start Date: August 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582049

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of Pennsylvania
New York Presbyterian Hospital
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Ira Dunkel, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ira Dunkel, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582049     History of Changes
Other Study ID Numbers: 03-030
Study First Received: December 21, 2007
Last Updated: July 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Retinoblastoma
Sporadic heritable retinoblastoma
Paternal exposures

Additional relevant MeSH terms:
Retinoblastoma
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
Retinal Diseases

ClinicalTrials.gov processed this record on October 02, 2014