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Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00897546
Enrollment
1716
Registered
2009-05-12
Start date
2007-06-01
Completion date
2008-07-01
Last updated
2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma, stage IV melanoma, stage IA melanoma, stage IB melanoma, stage IIA melanoma, stage IIB melanoma, stage IIC melanoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma

Brief summary

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.

Detailed description

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.

Interventions

OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of melanoma OR healthy volunteer (control) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

MeasureTime frameDescription
Generation of a comprehensive multiplexed array of melanoma-associated serological markers1 monthGeneration of a comprehensive multiplexed array of melanoma-associated serological markers

Secondary

MeasureTime frameDescription
Changes in the profile of serological markers induced by interferon-alfa 2b therapy1 monthChanges 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 response1 monthPanels of serological markers with prognostic and predictive power for interferon-alfa 2b response

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026