Clinical trial NCT00348088: Melanoma Biomarker Study
Official title: CXCL1 Biomarker Study in Metastatic Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Melanoma
Keywords: Metastatic
Melanoma
Untreated
Biomarker
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-07-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Malignant Melanoma

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.

Detailed description: 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 investigation.

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.

Aims:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Observational study only
timeFrame: May 2006-September 2011
Secondary outcomes:
measure: Observational study only
timeFrame: May 2006-September 2011
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
name: William H Sharfman, MD
role: PRINCIPAL_INVESTIGATOR
References: