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Retinoblastoma Biomarker Study

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ClinicalTrials.gov Identifier: NCT00342797
Recruitment Status : Active, not recruiting
First Posted : June 21, 2006
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A series of 1,729 retinoblastoma (RB) patients were identified from medical records at hospital centers in Boston (1937-84) and New York (1914-84). The study cohort consists of the 1,604 patients who survived at least 1 year after RB diagnosis. Information was obtained from medical records and interviews conducted in 1987 and 1993. RB patients had a 30-fold excess risk of another cancer, and a 50% chance of developing a cancer if they survived to 50 years of age. Blood samples have been collected from 481 patients, and studies are underway to determine if certain mutations in the RB1 genes are associated with increased or decreased penetrance or with increased risk of subsequent cancer development. The study population in New York is being expanded currently to include patients treated since 1984, and their medical records are being abstracted. Blood samples will be collected from the newly identified patients who are returning to New York Hospital for a followup RB exam.

Condition or disease
Retinoblastoma

Detailed Description:
A series of 1,729 retinoblastoma (RB) patients were identified from medical records at hospital centers in Boston (1937-84) and New York (1914-84). The study cohort consists of the 1,604 patients who survived at least 1 year after RB diagnosis. Information was obtained from medical records and interviews conducted in 1987 and 1993. RB patients had a 30-fold excess risk of another cancer, and a 50% chance of developing a cancer if they survived to 50 years of age. Blood samples have been collected from 481 patients, and studies are underway to determine if certain mutations in the RB1 genes are associated with increased or decreased penetrance or with increased risk of subsequent cancer development. The study population in New York is being expanded currently to include patients treated since 1984, and their medical records are being abstracted. Blood samples will be collected from the newly identified patients who are returning to New York Hospital for a followup RB exam.

Study Design

Study Type : Observational
Estimated Enrollment : 1995 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retinoblastoma Biomarker Study
Study Start Date : November 17, 1993

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Mutation in RB1 gene [ Time Frame: once ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Children treated for retroblastoma over the past 30-plus years.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342797


Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ruth A Kleinrock National Cancer Institute (NCI)
More Information

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00342797     History of Changes
Other Study ID Numbers: 999993033
OH93-NC-N033
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: August 25, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
second primary cancer
retinoblastoma
RB1 germline mutation

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