Melanoma (Skin)NCT00897481
Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy
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: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- gene expression analysis, mutation analysis and diagnostic laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of cutaneous melanoma
- Breslow thickness > 0.75 mm
- Has undergone sentinel lymph node biopsy
- No primary melanoma that has not originated in the skin
- No multiple primary melanomas
- Currently under clinical followup OR discharged from follow up within the past 3 months
PATIENT CHARACTERISTICS:
- No other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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
Julia Newton Bishop, MD, 44-113-206-4668
About this study
Official title: A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.
Read the detailed description
OBJECTIVES:
- Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy.
- Develop a survival model for relapse based on sentinel lymph node biopsy positivity.
- Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma.
OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs > 4 mm) and gender.
Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A).
Patient data related to relapse and recurrence is collected, if available.
Peer reviewed and funded or endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- gene expression analysis, mutation analysis, diagnostic laboratory biomarker analysis, immunohistochemistry staining method, sentinel lymph node biopsy
- Keywords
- stage IV melanoma, recurrent 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
diagnostic laboratory biomarker analysisOther
sentinel lymph node biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive model for sentinel lymph node biopsy positivity
Survival model for relapse
Genetic determinants in primary melanomas that predict a metastatic phenotype
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2007
- Primary completionSep 2011 (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
- 1,000 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
- NCT00897481
- Sponsor's protocol ID
- CRUK-LCC-06/Q1206/149
- Other IDs
- CDR0000532943, EU-20706
- Status last verified
- Apr 2008
- First submitted
- 9 May 2009
- 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
- A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy
- ClinicalTrials.gov ID
- NCT00897481
- Acronym / sponsor ID
- CRUK-LCC-06/Q1206/149
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma, stage IIC melanoma, stage IIIA melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Leeds Cancer Centre at St. James's University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2011 (estimated)
- First posted
- 12 May 2009 (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: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.
Detailed description
OBJECTIVES:
- Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy.
- Develop a survival model for relapse based on sentinel lymph node biopsy positivity.
- Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma.
OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs > 4 mm) and gender.
Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A).
Patient data related to relapse and recurrence is collected, if available.
Peer reviewed and funded or endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 | – |
| diagnostic laboratory biomarker analysis | Other | – |
| immunohistochemistry staining method | Other | – |
| sentinel lymph node biopsy | Procedure or surgery | – |
Primary outcome
Predictive model for sentinel lymph node biopsy positivity
Survival model for relapse
Genetic determinants in primary melanomas that predict a metastatic phenotype
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.
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?
Predictive model for sentinel lymph node biopsy positivity. The study lists 3 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.