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

A Retrospective Case-Control Study of Melanoma Patients Who Have Undergone Sentinel Lymph Node Biopsy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00897481
Enrollment
1000
Registered
2009-05-12
Start date
2007-01-31
Completion date
Unknown
Last updated
2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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, stage IIIB melanoma, stage IIIC melanoma

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.

Interventions

GENETICgene expression analysis
GENETICmutation analysis
OTHERdiagnostic laboratory biomarker analysis
OTHERimmunohistochemistry staining method
PROCEDUREsentinel lymph node biopsy

Sponsors

Leeds Cancer Centre at St. James's University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Predictive model for sentinel lymph node biopsy positivity
Survival model for relapse
Genetic determinants in primary melanomas that predict a metastatic phenotype

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026