NCT01131208

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 well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2010

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

May 25, 2010

Last Update Submit

May 16, 2017

Conditions

Lymphoma

Keywords

contiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomarecurrent adult diffuse large cell lymphomastage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (2)

  • Identification of genes predictive of clinical outcome

    1 month

  • Identification of genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy

    1 month

Interventions

gene expression analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age60 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: * Diagnosis of diffuse large B-cell lymphoma * Treated with CHOP or R-CHOP on ECOG-E4494 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, Large B-Cell, Diffuse

Interventions

Gene Expression Profiling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative Techniques

Study Officials

  • Jane N. Winter, MD

    Robert H. Lurie Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 25, 2010

First Posted

May 26, 2010

Study Start

April 21, 2010

Primary Completion

August 21, 2010

Study Completion

August 21, 2010

Last Updated

May 17, 2017

Record last verified: 2017-05