NCT00897546

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,716

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

May 9, 2009

Last Update Submit

May 17, 2017

Conditions

Melanoma (Skin)

Keywords

recurrent melanomastage IV melanomastage IA melanomastage IB melanomastage IIA melanomastage IIB melanomastage IIC melanomastage IIIA melanomastage IIIB melanomastage IIIC melanoma

Outcome Measures

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

    1 month

Secondary Outcomes (2)

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

    1 month

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

    1 month

Interventions

laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients participating in E1690 and E1694

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17438101RESULT

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elieser Gorelik, MD, PhD

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

June 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 19, 2017

Record last verified: 2017-05