Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma
|ClinicalTrials.gov Identifier: NCT00897546|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Melanoma (Skin)||Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||1716 participants|
|Official Title:||Multiplex Analysis of Serum Biomarkers for Prediction Interferon Therapy Response in Melanoma Patients|
|Actual Study Start Date :||June 1, 2007|
|Primary Completion Date :||July 1, 2008|
|Study Completion Date :||July 1, 2008|
- Generation of a comprehensive multiplexed array of melanoma-associated serological markers [ Time Frame: 1 month ]Generation of a comprehensive multiplexed array of melanoma-associated serological markers
- Changes in the profile of serological markers induced by interferon-alfa 2b therapy [ Time Frame: 1 month ]Changes in the profile of serological markers induced by interferon-alfa 2b therapy
- Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response [ Time Frame: 1 month ]Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897546
|Study Chair:||Elieser Gorelik, MD, PhD||University of Pittsburgh|