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CXCL1 Biomarker Study in Metastatic Melanoma

18 Years
Not Enrolling
Metastatic Melanoma

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Trial Information

CXCL1 Biomarker Study in Metastatic Melanoma

Malignant Melanoma has rapidly increased in incidence over the past thirty years, at a rate
of roughly 3% per year. In 2005, approximately 59,000 new cases of melanoma were diagnosed
with 8000 deaths. While the majority of early melanomas can be surgically cured, advanced
melanoma has an extremely poor prognosis. Current chemotherapy and immunotherapy options for
advanced melanoma still offer response rates of only 10-20%. Thus, the elucidation of
biomarkers in melanoma, both diagnostic and prognostic, is an important area for

CXCL1 is a chemokine whose expression is upregulated in melanoma. We postulate that CXCL1
plays an important role in the progression of melanoma to invasive disease. Our hypothesis
states that serum CXCL1 levels correlate with the presence of melanoma.


1. To measure serum levels of CXCL1 in untreated, metastatic melanoma patients and to
compare to serum CXCL1 levels in normal controls.

2. To measure and compare centrally and peripherally collected serum CXCL1 levels in
untreated, metastatic melanoma.

Blood will be collected from metastatic melanoma patients on one occasion, both peripherally
and centrally. Control will have blood collected peripherally on one occasion. The blood
will be processed and then tested in a blinded, batched fashion.

Inclusion Criteria:

1. Histologic diagnosis of melanoma; primary may be cutaneous, mucosal or ocular.

2. Evidence of metastatic disease based on standard AJCC staging.

3. Willing to give written informed consent.

4. Willing and able to comply with protocol procedures.

5. At least 18 years of age.

6. No prior chemotherapy, immunotherapy, or radiotherapy.

7. Are able to safely donate 50 mL of blood.

8. Have a central venous catheter in place (this will not be placed for participation in
this trial)

Exclusion Criteria:

1. Known diagnosis of a chronic inflammatory disease, ie: Rheumatoid Arthritis, Systemic
Sclerosis, Inflammatory bowel disease

2. Known diagnosis of NYHA class 3 or 4 Congestive Heart Failure

3. Are unable to safely donate 50 mL blood

4. Known HIV, Hepatitis B, or Hepatitis C infection.

5. 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Observational study only

Outcome Description:

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.

Outcome Time Frame:

May 2006-September 2011

Safety Issue:


Principal Investigator

William H Sharfman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2006

Completion Date:

September 2011

Related Keywords:

  • Metastatic Melanoma
  • Metastatic
  • Melanoma
  • Untreated
  • Biomarker
  • Melanoma



Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland  21231