Differential Risks for Melanoma: p16 and DNA Repair - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center University of New Mexico Yale University
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00615095

Purpose

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. 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. Genes are made up of DNA. DNA damage is one of the first steps in developing cancer. Each person has many ways to repair normal damage to their genes. Some people may have a lower level of this repair and that may make them more likely to get cancer. Some genes are important for DNA repair. The genes we want to test are thought to affect the rate at which DNA can be repaired. We also want to find out if sun habits are related to these levels of DNA repair or genetic mutations.

Condition	Intervention
Melanoma Skin Melanoma	Other: self-administered questionnaire and blood draw Other: self-administered questionnaire and blood draw Other: health questionnaire, blood draw and skin exam

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Differential Risks for Melanoma: p16 and DNA Repair

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

evaluate the relative risks of develop melanoma for those individuals with deficient DNA repair in a case-control study of multiple primary melanoma, where the controls are cases of first primary melanoma & healthy subjects from the general population. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

is to investigate associations of specific polymorphisms of the melanocortin receptor gene with clinical cutaneous phenotype (hair color, eye color, skin color, and freckling tendency). [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood

Estimated Enrollment:	323
Study Start Date:	February 1997
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Cases will be patients 18 years or older with a histologically confirmed, second or multiple primary melanoma.	Other: self-administered questionnaire and blood draw Epidemiologic data will be collected via a self-administered questionnaire which will be distributed to subjects by a member of the study staff. It should take less than fifteen minutes to complete, and subjects will have the options of completing it at the time of their blood-drawing or filling it out at home and mailing it back to the study staff.
2 Controls will be patients 18 years or older with a histologically confirmed first primary melanoma diagnosed no earlier than 12 months prior to the study start date.	Other: self-administered questionnaire and blood draw Epidemiologic data will be collected via a self-administered questionnaire which will be distributed to subjects by a member of the study staff. It should take less than fifteen minutes to complete, and subjects will have the options of completing it at the time of their blood-drawing or filling it out at home and mailing it back to the study staff.
3 Healthy controls will be subjects 18 years or older recruited from the general population through random digit dialing. These subjects will have no history of melanoma. They will also be frequency matched to cases on the basis of sex and 10-year age group.	Other: health questionnaire, blood draw and skin exam Numbers will be randomly selected from a pool of prefixes. Numbers will be screened by computer for being working, non-business, non-fax, and non-modem numbers. After establishing eligibility for the study, we will send the potential control a letter further explaining the purpose of the study and its requirements. An interviewer will then call to arrange an appointment. During the interview, the subject will sign informed consent, be given the public health questionnaire, have 30 ml of blood drawn, and undergo the skin examination of arms and back.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Second or multiple primary melanoma cases will be identified at Memorial Sloan-Kettering Cancer Center, the Yale University Pigmented Lesion Clinic, or from among those subjects who participated in the earlier case-control study in Connecticut.

First primary melanoma cases will be identified and referred to the study staff by participating physicians on the Melanoma Disease Management Team at Memorial Sloan-Kettering Cancer Center.

Random digit dialing will be used to locate 100 population-based controls for this study. We will use telephone prefixes in Connecticut

Criteria

Inclusion Criteria:

Cases will be patients 18 years or older with a histologically confirmed, second or multiple primary melanoma. These will be sequentially selected from subjects seen at Memorial Sloan-Kettering Cancer Center or the Yale University Pigmented Lesion Clinic.
Controls will be patients 18 years or older with a histologically confirmed first primary melanoma diagnosed no earlier than 12 months prior to the study start date. One control will be selected per case. These patients will be referred to the study by the Melanoma Disease Management Team at Memorial Sloan-Kettering Cancer Center. Controls will be frequency-matched to cases on the basis of sex and age (within 10 year age groups).
Healthy controls will be subjects 18 years or older recruited from the general population through random digit dialing. These subjects will have no history of melanoma. They will also be frequency matched to cases on the basis of sex and 10-year age group.
The subject must have a histologically confirmed malignant melanoma.
Cases may have an in situ melanoma as the second primary.
Melanoma Controls may have only one primary melanoma.
Healthy controls should have no history of melanoma.
The subject's physician consents to his/her patient's participation in the study (if the subject has a diagnosis of melanoma).
The subject has consented, in writing, to participate in the study

Exclusion Criteria:

Karnofsky status less than 60 (see Appendix). This will be evaluated by the physician treating the subject for melanoma at the time permission is given for participation
Patient had chemotherapy or radiation therapy within the last 6 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615095

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

University of New Mexico

Yale University

Investigators

Principal Investigator:

Irlene Orlow, PH.D., M.S.

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( IRENE ORLOW, PH.D., M.S. )
Study ID Numbers:	97-012
Study First Received:	February 1, 2008
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00615095
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Melanoma, familial

Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 14, 2009