NCT01563861

Brief Summary

RATIONALE: Studying samples of tumor 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 find better ways to treat cancer. PURPOSE: This research trial studies genes in samples from patients with limited and advanced diffuse large B-cell lymphoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1997

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

September 15, 1997

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2013

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

10.7 years

First QC Date

March 23, 2012

Last Update Submit

December 18, 2019

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (3)

  • Proportion of GCB phenotype among limited-stage vs advanced-stage patients

    Retrospectively

  • Differences in PFS between limited- and advanced-stage patients with the GCB and non-GCB phenotypes

    Retrospectively

  • Association between GCB markers and OS

    Retrospectively

Interventions

Eligibility Criteria

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

Patients registering to S9704-S0014-S0313 consenting to banking

DISEASE CHARACTERISTICS: * Diffuse large B-cell lymphoma - Initial diagnostic tissue block, or 4 unstained slides * Tissue from patients with limited-stage DLBCL enrolled on SWOG trials treated with cyclophosphamide, doxorubicin hydrochloride, prednisone, and vincristine sulfate (CHOP), and monoclonal anti-CD20 antibody backbone * SWOG-S0014 * SWOG-S0313 * Tissue from patients with advanced-stage DLBCL enrolled on SWOG trials treated with CHOP and monoclonal anti-CD20 antibody backbone * SWOG-S9704 * SWOG-S0433 * SWOG-S0515 * SWOG-S0806 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 ProfilingImmunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Daniel O. Persky, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 23, 2012

First Posted

March 27, 2012

Study Start

September 15, 1997

Primary Completion

June 1, 2008

Study Completion

October 31, 2013

Last Updated

December 20, 2019

Record last verified: 2019-12