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Molecular Epidemiology of Cutaneous Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00341991
First received: June 19, 2006
Last updated: May 21, 2016
Last verified: May 2016
  Purpose

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.


Condition
Melanoma

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Molecular Epidemiology of Cutaneous Malignant Melanoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To identify genes, host and environmental factors that lead to susceptibility to melanoma. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 17500
Study Start Date: October 2001
Detailed Description:

The original case-control study was planned to investigate the link of solar radiation with gene damage, host factors, including also genetic variants, and DNA repair proficiency in cutaneous malignant melanoma (CMM) risk, in subjects from the Mediterranean area, characterized by a wide range of pigmentary characteristics and intense sun exposure. This study was reviewed and funded as an R01 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 reactiviation assay, and sun exposure was evaluated by means of a detailed questionnaire. Minimal erythemal dosage was measured in all subjects to estimate skin sun sensitivity 24 hours after skin's UVirradiation. Skin color was ascertained on the inner side of the forearm by means of a minolta chromometer.

The aim of this protocol was to continue the analysis of the biological samples and data already collected, as originally outlined in the study protocol. However, the original sample size was small and precluded specific analyses of gene-environment interaction crucial for the understanding of the etiology of melanoma. We have identified other collaborators willing to share their data and sample with us to increase the power for statistical analyses. We obtained approval (amendments to 02-C-N035 approved in November 2006, September 2008, December 2010, and June 2011) to use the DNA samples and data collected in four studies conducted by investigators at the University of L'Aquila, Italy, University of Genoa, Italy, Istituto Valenciano de Oncologia, Valencia, Spain, and the New York University School of Medicine, respectively. We have obtained approval with stipulations in August 2014 to also include samples and data collected from the Papa Giovanni XXII Hospital in Bergamo, Italy and the University of Athens, Greece. We are now responding to the stipulations and asking to further include samples from the University of Padua and the Hospital Clinic of Barcelona within the same study.

We are currently analyzing genes in several pathways, including pigmentation, DNA repair, immune-related functions and those involved in the transition from nevi to melanoma (genes in the cell cycle, telomere, signaling pathways, etc). With the additional samples we plan to conduct a GWAS analysis of melanoma in Mediterranean countries and a molecular analysis of melanoma tissue lesions for an improved classification of the disease and its association with melanoma progression.

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Analysis on samples already collected.
  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: NCT00341991

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: Maria T Landi, M.D. National Cancer Institute (NCI)
  More Information

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00341991     History of Changes
Other Study ID Numbers: 999902035  02-C-N035 
Study First Received: June 19, 2006
Last Updated: May 21, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
DNA Repair
Genes
Pigmentation
Skin Cancer
Sun Exposure

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 23, 2016