MelanomaNCT00615095
Differential Risks for Melanoma: p16 and DNA Repair
An observational study of Melanoma and Skin Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Skin Melanoma
- What is being tested?
- self-administered questionnaire and blood draw and health questionnaire, blood draw and skin exam
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1997to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Melanoma, Skin Melanoma
- Being tested
- self-administered questionnaire and blood draw, health questionnaire, blood draw and skin exam
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered questionnaire and blood drawOther
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.
self-administered questionnaire and blood drawOther
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.
health questionnaire, blood draw and skin examOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cases will be patients 18 years or older with a histologically confirmed, second or multiple primary melanoma. Receives: Other: self-administered questionnaire and blood draw | |
| 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. Receives: Other: self-administered questionnaire and blood draw | |
| 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. Receives: Other: health questionnaire, blood draw and skin exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: conclusion of study
Secondary outcomes (1)
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).
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startFeb 1997
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Yale University
- Investigators
- Irlene Orlow, PH.D., M.S., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615095
- Sponsor's protocol ID
- 97-012
- Status last verified
- Apr 2011
- First submitted
- 1 Feb 2008
- Last updated
- 20 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Risks for Melanoma: p16 and DNA Repair
- ClinicalTrials.gov ID
- NCT00615095
- Acronym / sponsor ID
- 97-012
- Conditions
- Melanoma, Skin Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of New Mexico, Yale University
- Study start
- Feb 1997
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: self-administered questionnaire and blood drawCases will be patients 18 years or older with a histologically confirmed, second or multiple primary melanoma. |
| 2 | – | Other: self-administered questionnaire and blood drawControls 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. |
| 3 | – | Other: health questionnaire, blood draw and skin examHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-administered questionnaire and blood drawEpidemiologic 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. | Other | 1 |
| self-administered questionnaire and blood drawEpidemiologic 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. | Other | 2 |
| health questionnaire, blood draw and skin examNumbers 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. | Other | 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irlene Orlow, PH.D., M.S. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Skin Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: conclusion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2011.