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OpenTrials
Completed

NCT Number: NCT00897546

Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma

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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Key information

Conditions

Melanoma (Skin) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of melanoma OR healthy volunteer (control)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Treatment and study plan

laboratory biomarker analysis

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Multiplex Analysis of Serum Biomarkers for Prediction Interferon Therapy Response in Melanoma Patients

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 12, 2009
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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