Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342797
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2006-06-19
Brief Title:
Retinoblastoma Biomarker Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Retinoblastoma Biomarker Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Retinoblastoma is a rare pediatric ocular tumor caused by germline andor somatic mutations in the tumor suppressor gene RB1 Survivors of retinoblastoma particularly those with the hereditary form of the disease germline RB1 mutations are highly susceptible to developing additional malignancies which are a major cause of morbidity and mortality Since 1984 REB has followed a cohort of 2136 including 1995 one-year retinoblastoma survivors to investigate the contributions of treatment and genetic risk factors to second cancer etiology The last systematic follow-up for second cancer incidence and cause-specific mortality was completed in 2009 As the cohort ages we now propose to conduct another interview survey to collect information on newly diagnosed second cancers Additionally we propose to expand collection of germline DNA for additional molecular studies in survivors Retinoblastoma survivors have now entered adult ages when epithelial tumors would be expected to occur with greater frequency Given that the somatic mutations in the RB1 pathway have been identified in several epithelial tumors bladder brain breast esophagus liver lung prostate in addition to sarcomas it is important to collect new information on these epithelial tumors and to investigate whether the previously identified high risks of sarcomas and melanoma will persist as the cohort ages Additionally our understanding of genetic susceptibility to second cancers is limited Given that this is the only cohort of long-term survivors of retinoblastoma being followed in the US combined with the leadership role of REB in the study of second cancers continued follow-up of this cohort will provide unique clinical and epidemiologic data on the long-term cumulative risk of second cancers in this distinctive cohort of childhood cancer survivors
Detailed Description:
Retinoblastoma is a rare pediatric ocular tumor caused by germline andor somatic mutations in the tumor suppressor gene RB1 Survivors of retinoblastoma particularly those with the hereditary form of the disease germline RB1 mutations are highly susceptible to developing additional malignancies which are a major cause of morbidity and mortality Since 1984 REB has followed a cohort of 2136 including 1995 one-year retinoblastoma survivors to investigate the contributions of treatment and genetic risk factors to second cancer etiology The last systematic follow-up for second cancer incidence and cause-specific mortality was completed in 2009 As the cohort ages we now propose to conduct another interview survey to collect information on newly diagnosed second cancers Additionally we propose to expand collection of germline DNA for additional molecular studies in survivors Retinoblastoma survivors have now entered adult ages when epithelial tumors would be expected to occur with greater frequency Given that the somatic mutations in the RB1 pathway have been identified in several epithelial tumors bladder brain breast esophagus liver lung prostate in addition to sarcomas it is important to collect new information on these epithelial tumors and to investigate whether the previously identified high risks of sarcomas and melanoma will persist as the cohort ages Additionally our understanding of genetic susceptibility to second cancers is limited Given that this is the only cohort of long-term survivors of retinoblastoma being followed in the US combined with the leadership role of REB in the study of second cancers continued follow-up of this cohort will provide unique clinical and epidemiologic data on the long-term cumulative risk of second cancers in this distinctive cohort of childhood cancer survivors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH93-NC-N033 | None | None | None |