A Model for Genetic Susceptibility: Melanoma

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00591500
Collaborator
National Cancer Institute (NCI) (NIH), University of New Mexico (Other), University of North Carolina (Other), University of Michigan (Other), University of California, Irvine (Other), New South Wales Cancer Control (Other), University of Tasmania (Other), Registro dei Tumori, Torino, Italy (Other), British Columbia Cancer Agency (Other), Cancer Care Ontario (Other), University of Pennsylvania (Other)
4,082
1
284
14.4

Study Details

Study Description

Brief Summary

The goal of this study is to find out if some people are more likely to get melanoma, a form of skin cancer, than others are. To do this we will compare people who have had more than one melanoma to people who have had only one melanoma and to people who are similar but who have not developed melanoma.

People respond to the environment in different ways. Some may be born with genes that make them more likely to get this type of skin cancer. Each person has many ways to repair normal damage to their genes. Specific genes may affect the repair of sun damage. Other genes affect the way the skin itself reacts to the sun. We want to find out which genes have normal changes in them and lead to different responses to exposures, such as the sun. We also want to find out if sun habits are related to the way these genes work.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Questionnaire
  • Behavioral: Questionnaire

Detailed Description

The purpose of this study is to better understand genetic susceptibility to melanoma and the interactions of specific polymorphisms with each other and with environmental factors.

To accomplish this, buccal swabs or blood specimens from patients with melanoma (either single primary or multiple primary) have been collected. Specimens will be prepared in the Epidemiology Laboratory at MSKCC. They will be analyzed at MSKCC for INK4A (and functional assays for DNA repair capacity when blood is available) and the melanocortin gene (MC1R), at the University of North Carolina for polymorphisms in DNA repair genes and immune function genes, at the University of Pennsylvania for polymorphisms in the melanocortin receptor gene (MC1R) and immune function genes, and at the University of California (Irvine) for polymorphisms in metabolizing genes (P450's and GST's). Samples will be banked at MSKCC and the University of New Mexico. In order to perform this study, subjects from population-based registries in the United States (New Jersey, North Carolina, Michigan, San Diego/Imperial Counties), Canada (Cancer Care Ontario, British Columbia), Italy (Turin), Australia (New South Wales, Tasmania), were interviewed, asked to provide blood or buccal swab samples and asked to provide permission to obtain and review slides of their primary melanoma. This study is now closed to accrual.

Study Design

Study Type:
Observational
Actual Enrollment :
4082 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Model for Genetic Susceptibility: Melanoma
Actual Study Start Date :
Nov 1, 1999
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Control

The control group comprises patients with a first primary melanoma diagnosed in a twelve-month period.

Behavioral: Questionnaire
Exposures of interest will be measured by a self-administered personal residence, occupation and vacation calendar, a telephone interview, and by testing DNA from buccal cells and blood, when available. Standardization of diagnosis will be undertaken by review of tissue slides. Questionnaire data will be completed by interviewers. DNA will be obtained from each individual in the form of 4-6 buccal swabs

Cases

Cases are patients diagnosed with a second or higher order primary in a six-year period.

Behavioral: Questionnaire
Exposures of interest will be measured by a self-administered personal residence, occupation and vacation calendar, a telephone interview, and by testing DNA from buccal cells and blood, when available. Standardization of diagnosis will be undertaken by review of tissue slides. Questionnaire data will be completed by interviewers. DNA will be obtained from each individual in the form of 4-6 buccal swabs.

Outcome Measures

Primary Outcome Measures

  1. Comparison of INK4A and CDK4 mutation status and DNA repair gene, metabolizing gene, immune function gene, and melanocortin receptor gene polymorphism status; Interactions between polymorphisms and sun exposure history; Interactions among polymorphisms. [2 years]

Secondary Outcome Measures

  1. to examine psychosocial factors that predict skin cancer prevention behaviors including: participants' perceptions of future cancer risk, worry about cancer, self-efficacy, response-efficacy, and presence of family discussions about skin cancer risk. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • The subject must have a histologically confirmed invasive first primary melanoma newly diagnosed between January 1, 2000 and December 31, 2000.

OR the subject must have a histologically confirmed invasive or in situ second primary melanoma newly diagnosed between January 1, 1998 and December 31, 2003. One of the earlier primaries must be invasive melanoma OR the subject must be a randomly ascertained control from the general.

  • The patient must be a resident of a one of the specific geographic areas participating in this study.
Exclusion Criteria:
  • Subjects who do not speak English or Italian

  • Subject is unable to sign informed consent

  • Subject is unable to participate in telephone interview

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • National Cancer Institute (NCI)
  • University of New Mexico
  • University of North Carolina
  • University of Michigan
  • University of California, Irvine
  • New South Wales Cancer Control
  • University of Tasmania
  • Registro dei Tumori, Torino, Italy
  • British Columbia Cancer Agency
  • Cancer Care Ontario
  • University of Pennsylvania

Investigators

  • Principal Investigator: Arlene Orlow, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00591500
Other Study ID Numbers:
  • 99-087
  • CA83180
First Posted:
Jan 11, 2008
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022