- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00615095
Differential Risks for Melanoma: p16 and DNA Repair
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10065
- Memorial Sloan-Kettering Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
|
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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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.
Periodo de tiempo: conclusion of study
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conclusion of study
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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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).
Periodo de tiempo: conclusion of study
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conclusion of study
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Irlene Orlow, PH.D., M.S., Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 97-012
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