Melanoma (Skin)NCT00445783
Study of Families With Melanoma
An observational study of Melanoma (Skin), run by Leeds Cancer Centre at St. James's University Hospital at 1 site in United Kingdom.
Trial summary
RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse. PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma. 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)
- What is being tested?
- gene expression analysis, mutation analysis and immunohistochemistry staining method
- Type of treatment
- Surgery or procedure
- How many people
- 3,700 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2000to Dec 2020
- 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
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Newly diagnosed primary invasive melanoma (patient group)
- Lentigo maligna malignant melanoma allowed
- Rare variants of melanoma allowed, including any of the following:
- Acral lentiginous
- Subungual
- Ear, nose, and throat
- Oropharyngeal
- Perineal
- Vaginal
- Vulval
- Rectal
- Nodal with no known primary
- Patients undergoing sentinel node biopsy are eligible
- No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma
- Healthy participant meeting either of the following criteria (control group):
- Relative of a patient who was diagnosed with melanoma after September 2005
- Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Contact Person, 44-113-206-6400
About this study
Official title: Melanoma Family Case-Control Study Protocol
RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.
PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine what lifestyle factors and which genes govern relapse from melanoma.
Secondary
- Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.
- Assess how unusual moles relate to sun exposure and genes that cause melanoma.
OUTLINE: This is a multicenter, cohort study.
Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).
NOTE: *Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.
Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.
Patients and healthy participants are followed annually.
Peer reviewed and funded or endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- gene expression analysis, mutation analysis, immunohistochemistry staining method, laboratory biomarker analysis, examination
- Keywords
- lentigo maligna malignant melanoma, stage IV melanoma, acral lentiginous malignant melanoma, nodular malignant melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma, stage IIC melanoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
mutation analysisGenetic
laboratory biomarker analysisOther
examinationProcedure or surgery
mutation carrier screeningProcedure or surgery
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle factors governing relapse from melanoma
Genes governing relapse from melanoma
Sun exposure and genes that cause melanoma
Unusual moles related to sun exposure and genes that cause melanoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startJul 2000
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- 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
- Enrolment
- 3,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds Cancer Centre at St. James's University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Julia Newton Bishop, MD, Study chair, Leeds Cancer Centre at St. James's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445783
- Sponsor's protocol ID
- CRUK-LCC-1/3/57
- Other IDs
- CDR0000532934, EU-20704
- Status last verified
- Apr 2008
- First submitted
- 7 Mar 2007
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Family Case-Control Study Protocol
- ClinicalTrials.gov ID
- NCT00445783
- Acronym / sponsor ID
- CRUK-LCC-1/3/57
- Conditions
- Melanoma (Skin)
- Keywords
- lentigo maligna malignant melanoma, stage IV melanoma, acral lentiginous malignant melanoma, nodular malignant melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,700 participants (estimated)
- Lead sponsor
- Leeds Cancer Centre at St. James's University HospitalUniversity, hospital or other
- Study start
- Jul 2000
- Primary completion
- Dec 2020 (estimated)
- First posted
- 9 Mar 2007 (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.
RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse.
PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine what lifestyle factors and which genes govern relapse from melanoma.
Secondary
- Compare sun exposure and genes that cause melanoma in patients with melanoma vs healthy participants.
- Assess how unusual moles relate to sun exposure and genes that cause melanoma.
OUTLINE: This is a multicenter, cohort study.
Patients and healthy participants complete lifestyle questionnaires by mail and telephone. Some patients* and healthy participants undergo a skin examination to count moles and classify skin type (e.g., degree of freckling and wrinkling indicative of sun damage).
NOTE: *Patients diagnosed with primary invasive melanoma after September 2005 do not need to consent to a skin examination.
Patients and healthy participants also undergo blood collection for lymphocyte analysis, DNA extraction, and the measurement of minerals, vitamins, and beta carotene. Tissue samples from original diagnosis are examined by immunohistochemistry for gene expression and mutations, including CDKN2A and CDK4.
Patients and healthy participants are followed annually.
Peer reviewed and funded or endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 3,700 patients and healthy participants will be accrued for this study.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| examination | Procedure or surgery | – |
| mutation carrier screening | Procedure or surgery | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Lifestyle factors governing relapse from melanoma
Genes governing relapse from melanoma
Sun exposure and genes that cause melanoma
Unusual moles related to sun exposure and genes that cause melanoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Julia Newton Bishop, MD study chair
Leeds Cancer Centre at St. James's University Hospital
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 (Skin), run by Leeds Cancer Centre at St. James's University Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifestyle factors governing relapse from melanoma. The study lists 4 primary outcomes in all. 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 12 Aug 2013.