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NCT00341991 · ClinicalTrials.gov registry record
Molecular Epidemiology of Cutaneous Malignant Melanoma
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 15,401
- Enrollment target
NCT00341991: Completed study, sponsored by National Cancer Institute (NCI).
NCT00341991 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 15,401 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00341991 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 15,401 participants
- Enrollment target
Study Summary
This case-control study was planned to investigate the link of solar radiation with gene damage, host factors, and DNA repair proficiency in cutaneous malignant melanoma (CMM) risk. The hypothesis was that impaired DNA repair proficiency is associated with an increased risk of CMM due to unrepaired DNA damage, particularly in subjects with dysplastic nevi, poor tanning ability or genetic susceptibility. The study was reviewed as an RO1 Grant from the National Cancer Institute in 1995. Subject enrollment, which included clinical evaluation, epidemiologic questionnaires, and skin and blood sample collection, was completed in 1999 on approximately 180 melanoma cases and 180 controls identified in Italy. The study protocol and consent form both included the measurement of genetic and biochemical factors and DNA repair capacity. DNA repair proficiency was measured in lymphocytes by the host cell reactivation assay, and sun exposure was evaluated by means of a detailed questionaire. Photographs of the back of the subjects were taken to allow nevi count. Minimal erythemal dosage was measured in all subjects to estimate skin sun sensitivity 24 hours after skin's UV-irradiation. Skin color was ascertained on the inner side of the forearm by means of a Minolta chromometer. The aim of this protocol is to continue analysis of the biological samples already collected, as originally outlined in the study protocol. In particular, we plan to measure polymorphisms in genes that may lead to susceptibility to melanoma. Initially we will concentrate on variation in genes involved in repairing damaged DNA, but plan to look at a broad group of candidate susceptibility genes.
Primary Outcome
To identify genes, host and environmental factors that lead to susceptibility to melanoma.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15,401 participants |
| Start Date | 2001-11-01 |
| Est. Completion | 2020-06-26 |
What the finished NCT00341991 record still lists
NCT00341991 is an observational study that tracks outcomes without assigning an intervention. Its 15,401 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT00341991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00341991 about?
NCT00341991 is a clinical study titled "Molecular Epidemiology of Cutaneous Malignant Melanoma". This case-control study was planned to investigate the link of solar radiation with gene damage, host factors, and DNA repair proficiency in cutaneous malignant melanoma (CMM) risk. The hypothesis was that impaired DNA repair proficiency is associated with an increased risk of CMM due to unrepaired ...
What is the current status of trial NCT00341991?
This trial is currently completed. The enrollment target is 15,401 participants. The study started on 2001-11-01. Estimated completion is 2020-06-26.
Who is sponsoring clinical trial NCT00341991?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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