A Model for Genetic Susceptibility: Melanoma

NCT00591500 | Active Not Recruiting

• 2 other identifiers: 99-087CA83180
• Study Type: observational
• Target: 4,082
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Skin Cancer

Keywords

Melanoma; Skin cancer; Genetic Susceptibility; polymorphisms

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

Control

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

Behavioral: Questionnaire

Cases

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

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

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

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population-based registries in the United States

You may qualify if:

• \- 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.

You may not qualify if:

• Subjects who do not speak English or Italian
• Subject is unable to sign informed consent
• Subject is unable to participate in telephone interview

Sponsors & Collaborators

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

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering web site

Biospecimen

Retention: SAMPLES WITH DNA

buccal swabs tissue

MeSH Terms

Conditions

Melanoma; Skin Neoplasms; Genetic Predisposition to Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Arlene Orlow, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: November 1, 1999
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-08

Locations

US (1)