Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy
Primary Purpose
Melanoma (Skin)
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
gene expression analysis
mutation analysis
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
sentinel lymph node biopsy
Sponsored by
About this trial
This is an observational trial for Melanoma (Skin) focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Leeds Cancer Centre at St. James's University HospitalRecruiting
Outcomes
Primary Outcome Measures
Predictive model for sentinel lymph node biopsy positivity
Survival model for relapse
Genetic determinants in primary melanomas that predict a metastatic phenotype
Secondary Outcome Measures
Full Information
NCT ID
NCT00897481
First Posted
May 9, 2009
Last Updated
August 9, 2013
Sponsor
Leeds Cancer Centre at St. James's University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00897481
Brief Title
Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy
Official Title
A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy
Study Type
Observational
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Leeds Cancer Centre at St. James's University Hospital
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, stage IIIB melanoma, stage IIIC melanoma
7. Study Design
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Procedure
Intervention Name(s)
sentinel lymph node biopsy
Primary Outcome Measure Information:
Title
Predictive model for sentinel lymph node biopsy positivity
Title
Survival model for relapse
Title
Genetic determinants in primary melanomas that predict a metastatic phenotype
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Newton Bishop, MD
Organizational Affiliation
Leeds Cancer Centre at St. James's University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Newton Bishop, MD
Phone
44-113-206-4668
12. IPD Sharing Statement
Learn more about this trial
Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy
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