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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center University of Pennsylvania New York Presbyterian Hospital Children's Hospital Pennsylvania |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00582049 |
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 |
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Retinoblastoma |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Research on the Environment and Children's Health: Retinoblastoma |
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 |
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Cases: retinoblastoma patients
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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).
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Ira Dunkel, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Ira Dunkel, MD ) |
Study ID Numbers: | 03-030 |
Study First Received: | December 21, 2007 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00582049 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Retinoblastoma Sporadic heritable retinoblastoma Paternal exposures |
Retinal Neoplasms Neuroectodermal Tumors Eye Neoplasms Eye Diseases Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Retinoblastoma Retinal Diseases Neoplasms, Glandular and Epithelial |
Retinal Neoplasms Neoplasms by Histologic Type Eye Neoplasms Eye Diseases Neoplasms, Nerve Tissue Retinoblastoma Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Neuroepithelial Retinal Diseases Neoplasms, Glandular and Epithelial |