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

NCT00897481 | Unknown

• 3 other identifiers: CRUK-LCC-06/Q1206/149CDR0000532943EU-20706
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Predictive model for sentinel lymph node biopsy positivity

• Survival model for relapse

• Genetic determinants in primary melanomas that predict a metastatic phenotype

Interventions

gene expression analysis GENETIC

mutation analysis GENETIC

diagnostic laboratory biomarker analysis OTHER

immunohistochemistry staining method OTHER

sentinel lymph node biopsy PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Leeds Cancer Centre at St. James's University Hospital: lead

Study Sites (1)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Gene Expression Profiling; Immunohistochemistry; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Biopsy; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision

Study Officials

• Julia Newton Bishop, MD

  Leeds Cancer Centre at St. James's University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: January 1, 2007
• Primary Completion: September 1, 2011
• Last Updated: August 12, 2013

Record last verified: 2008-04

Locations

GB (1)