Differential Risks for Melanoma: p16 and DNA Repair
19. April 2011 aktualisiert von: Memorial Sloan Kettering Cancer Center
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
323
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10065
- Memorial Sloan-Kettering Cancer Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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.
Zeitfenster: conclusion of study
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conclusion of study
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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).
Zeitfenster: conclusion of study
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conclusion of study
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Irlene Orlow, PH.D., M.S., Memorial Sloan Kettering Cancer Center
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 1997
Primärer Abschluss (Tatsächlich)
1. April 2011
Studienabschluss (Tatsächlich)
1. April 2011
Studienanmeldedaten
Zuerst eingereicht
1. Februar 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Februar 2008
Zuerst gepostet (Schätzen)
14. Februar 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
20. April 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. April 2011
Zuletzt verifiziert
1. April 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 97-012
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