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Differential Risks for Melanoma: p16 and DNA Repair

18 Years
Not Enrolling
Melanoma, Skin Melanoma

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Trial Information

Differential Risks for Melanoma: p16 and DNA Repair

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

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

conclusion of study

Safety Issue:


Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 1997

Completion Date:

April 2011

Related Keywords:

  • Melanoma
  • Skin Melanoma
  • Melanoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021