NCT00897520

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment. PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

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

January 14, 2008

Completed
1.3 years 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2010

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 9, 2009

Last Update Submit

May 17, 2017

Conditions

Melanoma (Skin)

Keywords

stage II melanomastage III melanomastage IV melanoma

Outcome Measures

Primary Outcomes (2)

  • Serum sample screening via high throughput protein profiling in patients undergoing therapy

    1 month

  • Comparison of soluble factors

    1 month

Interventions

recombinant interferon alfaBIOLOGICAL
proteomic profilingGENETIC
immunoenzyme techniqueOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples submitted for research from patients participating in E1694

DISEASE CHARACTERISTICS: * Diagnosis of high-risk melanoma * Receiving interferon alfa-2b therapy in arm II of clinical trial E-1694 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

MeSH Terms

Conditions

Melanoma

Interventions

Interferon-alphaImmunoenzyme Techniques

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

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsImmunoassayImmunologic TechniquesInvestigative TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • Monica Panelli, 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

January 14, 2008

Primary Completion

January 24, 2010

Study Completion

January 24, 2010

Last Updated

May 19, 2017

Record last verified: 2017-05