Melanoma Biomarker Study

NCT00348088 | Completed

• 2 other identifiers: J05122NA_00001940
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the level of a specific protein, CXCL1, in the blood of patients with untreated, metastatic (Stage IV) melanoma. These levels will be compared to blood levels in normal controls. If the levels are elevated in metastatic melanoma, further studies to determine if this correlates with presence and extent of disease will be pursued.

Conditions

Metastatic Melanoma

Keywords

Metastatic; Melanoma; Untreated; Biomarker

Outcome Measures

Primary Outcomes (1)

• Observational study only

  To determine, via sandwiched ELISA, the presence and level of CXCL1 in the serum of patients with metastatic melanoma and to compare these values with CXCL1 levels in normal controls.

  May 2006-September 2011

Secondary Outcomes (1)

• Observational study only

  May 2006-September 2011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Malignant Melanoma

You may qualify if:

• Histologic diagnosis of melanoma; primary may be cutaneous, mucosal or ocular.
• Evidence of metastatic disease based on standard AJCC staging.
• Willing to give written informed consent.
• Willing and able to comply with protocol procedures.
• At least 18 years of age.
• No prior chemotherapy, immunotherapy, or radiotherapy.
• Are able to safely donate 50 mL of blood.
• Have a central venous catheter in place (this will not be placed for participation in this trial)

You may not qualify if:

• Known diagnosis of a chronic inflammatory disease, ie: Rheumatoid Arthritis, Systemic Sclerosis, Inflammatory bowel disease
• Known diagnosis of NYHA class 3 or 4 Congestive Heart Failure
• Are unable to safely donate 50 mL blood
• Known HIV, Hepatitis B, or Hepatitis C infection.
• Any malignancy within 5 years, other than melanoma (for patients); Have any malignancy within the past 5 years including melanoma (for normal controls). Basal cell and squamous cell skin cancers are permitted in all participants.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William H Sharfman, MD

  Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: May 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

US (1)