NCT00898963

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment. PURPOSE: This laboratory study is looking at biomarkers in patients with stage III or stage IV follicular lymphoma treated on clinical trial E-1496.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 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

April 18, 2007

Completed
2.1 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
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2011

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

3.8 years

First QC Date

May 9, 2009

Last Update Submit

July 29, 2020

Conditions

Keywords

stage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (4)

  • Correlation of gene expression profiles with progression-free survival (PFS)

    1 month

  • Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry

    1 month

  • Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers

    1 month

  • Correlation of relevant biomarkers with clinical features, response, and PFS

    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 submitted for research from patients participating in E1496

DISEASE CHARACTERISTICS: * Diagnosis of follicular lymphoma * Stage III or IV disease * Received cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496 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 AnalysisAmplified Fragment Length Polymorphism AnalysisImmunohistochemistryImmunologic Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesMicrochip Analytical ProceduresDNA FingerprintingPolymerase Chain ReactionNucleic Acid Amplification TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological Techniques

Study Officials

  • Randall D. Gascoyne, MD

    British Columbia Cancer Agency

    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

April 18, 2007

Primary Completion

February 11, 2011

Study Completion

February 11, 2011

Last Updated

July 31, 2020

Record last verified: 2020-07