Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1716 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-01

Study Completion Date

2008-07-01

Brief Summary

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RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon therapy in patients with melanoma.

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Detailed Description

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OBJECTIVES:

* Generate a comprehensive multiplexed array of melanoma-associated serological markers and validate it using serum samples from patients with melanoma and healthy control participants.
* Determine changes in the profile of serological markers induced by interferon-alfa 2b (IFN-α2b) therapy.
* Define panels of serological markers with prognostic and predictive power for IFN-α2b therapy responses in patients with melanoma.

OUTLINE: This is a multicenter study.

Serum samples are used for multiplex analyses. Biomarkers to be assessed include cytokines, chemokines, growth factors, angiogenic and antiangiogenic molecules, matrix metalloproteases (MMPs), tissue inhibitors of MMPs (TIMPs), melanoma-associated antigens, basic fibroblast growth factor, insulin-like growth factor I and II, thrombospondin, endostatin, angiostatin, vasostatin, and vascular endothelial growth factor inhibitor.

PROJECTED ACCRUAL: A total of 1,716 samples will be accrued for this study.

Conditions

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Melanoma (Skin)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of melanoma OR healthy volunteer (control)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes