Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy | Recruiting
Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Melanoma (Skin)
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruiting
Recruitment Status
NCT00897481
Primary Trial ID Number
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.
Research Details
  • 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.
Phase
N/A
Study Design
N/A
Study Type
Observational
Intervention
Genetic : gene expression analysis, Genetic : mutation analysis, Other : diagnostic laboratory biomarker analysis, Other : immunohistochemistry staining method, Procedure : sentinel lymph node biopsy

Study Arm Groups : , , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
  • Predictive model for sentinel lymph node biopsy positivity; null; Survival model for relapse; null; Genetic determinants in primary melanomas that predict a metastatic phenotype; null
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
N/A - N/A
Who Can Participate
Patients
Number of Participants
1000
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
St. James University Hospital
Leeds
LS9 7TF
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CRUK-LCC-06/Q1206/149
Sponsor(s)
Leeds Cancer Centre at St. James's University Hospital
Key Dates

Recruitment Start Date

Jan 2007

Recruitment End Date

Sep 2011

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

09 May 2009

Last Updated

09 Aug 2013