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CompletedNCT00897546Updated May 19, 2017

Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma

An observational study in Melanoma (Skin), sponsored by ECOG-ACRIN Cancer Research Group. Completed. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-19.

Sponsored by ECOG-ACRIN Cancer Research Group · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
1,716
Ages
18 Years to 120 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Melanoma (Skin)

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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
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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 1,716 is above the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

ECOG-ACRIN Cancer Research Group is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Samples submitted for research from patients participating in E1690 and E1694

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of melanoma OR healthy volunteer (control)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
1,716 participants (actual)

Interventions

  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Generation of a comprehensive multiplexed array of melanoma-associated serological markers

    Generation of a comprehensive multiplexed array of melanoma-associated serological markers

    Time frame: 1 month

Secondary outcomes

  1. Changes in the profile of serological markers induced by interferon-alfa 2b therapy

    Changes in the profile of serological markers induced by interferon-alfa 2b therapy

    Time frame: 1 month

  2. Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response

    Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Yurkovetsky ZR, Kirkwood JM, Edington HD, Marrangoni AM, Velikokhatnaya L, Winans MT, Gorelik E, Lokshin AE. Multiplex analysis of serum cytokines in melanoma patients treated with interferon-alpha2b. Clin Cancer Res. 2007 Apr 15;13(8):2422-8. doi: 10.1158/1078-0432.CCR-06-1805. PubMed 17438101 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00897546
Lead sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Jun 1, 2007
Primary completion
Jul 1, 2008
Completion
Jul 1, 2008
Last update
May 19, 2017

Study contacts

Elieser Gorelik, MD, PhD
study chair · University of Pittsburgh
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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