NCT01150643

Brief Summary

RATIONALE: Studying the effects of rituximab in blood and tumor tissue samples from patients with cancer in the laboratory may help doctors learn more about the effects of rituximab on cancer cells. It may also help doctors identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in samples from patients with follicular lymphoma treated with rituximab.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
559

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

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

First Submitted

Initial submission to the registry

June 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

December 6, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2011

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

June 24, 2010

Last Update Submit

May 16, 2017

Conditions

Keywords

stage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • Correlation between FcγR polymorphisms and rituximab response, response duration, and time to resistance

    1 month

Interventions

Eligibility Criteria

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

Samples from patients enrolled on E4402 from whom samples were submitted for research

DISEASE CHARACTERISTICS: * Diagnosed with follicular lymphoma * Treated on ECOG-E4402 comprising 1 of 2 different rituximab-dose strategies * Banked peripheral blood mononuclear cells (PBMCs) and formalin-fixed paraffin-embedded (FFPE) tumor samples available 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

LymphomaLymphoma, Follicular

Interventions

Gene Expression ProfilingMicroarray AnalysisPolymerase Chain ReactionAmplified Fragment Length Polymorphism AnalysisImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesMicrochip Analytical ProceduresNucleic Acid Amplification TechniquesDNA FingerprintingHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Brad S. Kahl, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 24, 2010

First Posted

June 25, 2010

Study Start

December 6, 2010

Primary Completion

January 6, 2011

Study Completion

January 6, 2011

Last Updated

May 17, 2017

Record last verified: 2017-05