- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00615095
Differential Risks for Melanoma: p16 and DNA Repair
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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1
Cases will be patients 18 years or older with a histologically confirmed, second or multiple primary melanoma.
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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.
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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conclusion of study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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conclusion of study
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Collaborators and Investigators
Investigators
- Principal Investigator: Irlene Orlow, PH.D., M.S., Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 97-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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