Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma

NCT00004153 | Completed

• 4 other identifiers: 9308UCCRC-9308UCCRC-CTRC-9767NCI-G99-1620
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Diagnostic procedures may improve the ability to detect the presence or recurrence of disease. PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood of patients who have melanoma.

Conditions

Melanoma (Skin)

Keywords

stage I melanoma; stage II melanoma; stage III melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease

  3 years

Interventions

reverse transcriptase-polymerase chain reaction GENETIC

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: * Clinically proven melanoma with indication to perform sentinel lymph node biopsy or elective lymph node dissection OR * Histologically proven or diagnosis highly suspicious for melanoma PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 50,000/mm\^3 * Hemoglobin greater than 7 g/dL Hepatic: * PT less than 15 sec * PTT less than 30 sec Renal: * Not specified Other: * No psychiatric illness that precludes compliance * No other concurrent malignancy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Reverse Transcriptase Polymerase Chain Reaction; 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)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision

Study Officials

• Thomas F. Gajewski, MD, PhD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: January 27, 2003
• Study Start: June 1, 1998
• Primary Completion: March 1, 2004
• Study Completion: January 1, 2005
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (1)