NCT01388569

Brief Summary

RATIONALE: Studying samples of blood from patients treated with sargramostim in the laboratory may help doctors learn more about the effects of sargramostim on cells. It may also help doctors understand how patients respond to treatment. PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV melanoma previously treated with sargramostim.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 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

June 28, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2011

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

July 2, 2011

Last Update Submit

May 16, 2017

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma

Outcome Measures

Primary Outcomes (1)

  • Overall and disease-free survival

    1 year

Interventions

flow cytometryOTHER
immunologic techniqueOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

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

Samples from patient enrolled on E4697 from whom samples were submitted for research

DISEASE CHARACTERISTICS: * Diagnosed with melanoma * Stage IV disease * HLA-A2\^+ and A2\^+ * Received sargramostim on clinical trial ECOG-4697 * Specimens collected at baseline and either day 43 or day 85 (based on most consistent availability) from long-term survivors and patients with poor survival 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

Flow CytometryImmunologic 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)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Lisa Butterfield, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 2, 2011

First Posted

July 6, 2011

Study Start

June 28, 2011

Primary Completion

September 28, 2011

Study Completion

September 28, 2011

Last Updated

May 17, 2017

Record last verified: 2017-05