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Retinoblastoma Biomarker Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00342797
First received: June 19, 2006
Last updated: September 14, 2016
Last verified: August 2016
  Purpose
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
Retinoblastoma

Study Type: Observational
Official Title: Retinoblastoma Biomarker Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1995
Study Start Date: November 1993
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.
  Eligibility

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

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

  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: 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 Kleinerman 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 
Study First Received: June 19, 2006
Last Updated: September 14, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
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

ClinicalTrials.gov processed this record on September 23, 2016