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NCT00340496 · ClinicalTrials.gov registry record
Analysis of NF2 Mutations in Radiation-Related Neural Tumors
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 112
- Enrollment target
NCT00340496: Completed study, sponsored by National Cancer Institute (NCI).
NCT00340496 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 112 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00340496 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 112 participants
- Enrollment target
Study Summary
Adults treated with X-rays in childhood for benign conditions such as enlarged tonsils and adenoids have an increased risk of developing nervous system tumors. The risk is highest for schwannomas (RR of 33.1, 95% CI of 9.4-116.5), intermediate for meningiomas (RR of 9.5, 95% CI of 3.5-25.7) and lowest for gliomas (RR of 2.6, 95% CI of 0.8-8.6). Studies of sporadic tumors of these types have demonstrated the presence of somatic mutations in the NF2 gene. Because these mutations are not usually seen in other types of tumors, they are believed to be what caused the sporadic neural tumors to develop. Germline mutations in the same gene are responsible for the autosomal dominant disorder known as neurofibromatosis 2 (NF2) which is characterized by the development of similar types of neural tumors. The purpose of the proposed study is to determine if neural tumors that developed in people who were treated with X-rays in childhood also have somatic NF2 mutations. This will be done using DNA from paraffin-embedded neural tumors that developed in \~ 112 individuals treated with X-rays in childhood for benign head and neck conditions. These individuals are from a cohort of over 4,000 irradiated persons followed by Michael Reese Hospital in Chicago since 1974. If we find NF2 mutations in the radiation-related tumors, we will determine whether they are somatic or germline by looking for NF2 mutations in DNA from buccal cells of the patients with the studied tumors. We expect that most patients will have NF2 mutations only in tumor DNA. However, there is a remote possibility that one or more patients may have a germline NF2 mutation and thus an increased risk of developing neural tumors even in the absence of X-ray treatment. We will then compare the types and frequencies of the somatic NF2 mutations with those found in sporadic neural tumors. If we do not find somatic NF2 mutations in the radiation-related tumors, we will conclude that X-rays caused neural tumors to develop t
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 1996-08 |
| Est. Completion | 2006-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00340496
The ClinicalTrials.gov registry entry for NCT00340496 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00340496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00340496 about?
NCT00340496 is a clinical study titled "Analysis of NF2 Mutations in Radiation-Related Neural Tumors". Adults treated with X-rays in childhood for benign conditions such as enlarged tonsils and adenoids have an increased risk of developing nervous system tumors. The risk is highest for schwannomas (RR of 33.1, 95% CI of 9.4-116.5), intermediate for meningiomas (RR of 9.5, 95% CI of 3.5-25.7) and lowe...
What is the current status of trial NCT00340496?
This trial is currently completed. The enrollment target is 112 participants. The study started on 1996-08. Estimated completion is 2006-07.
Who is sponsoring clinical trial NCT00340496?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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