NCT00896922

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 examining biological markers in patients with follicular lymphoma treated on clinical trial SWOG-8809, SWOG-9800, or SWOG-9911.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Typical duration 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

January 1, 2007

Completed
2.4 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
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

May 9, 2009

Last Update Submit

February 24, 2017

Conditions

Keywords

contiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage 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 (2)

  • Prognostic significance of MUM-1, lymphoma-associated macrophages, and regulatory T cells

    Retrospective

  • Comparison of prognostic significance in patients treated with chemotherapy alone vs chemotherapy and monoclonal antibody therapy

    Retrospective

Interventions

Eligibility Criteria

Age16 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled to S8809, S9800 and S9911 consenting to banking

DISEASE CHARACTERISTICS: * Diagnosis of follicular lymphoma * Previously treated on any of the following clinical trials: * SWOG-8809 * SWOG-9800 * SWOG-9911 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

Related Publications (2)

  • Sweetenham JW, Goldman B, LeBlanc ML, Cook JR, Tubbs RR, Press OW, Maloney DG, Fisher RI, Rimsza LM, Braziel RM, Hsi ED. Prognostic value of regulatory T cells, lymphoma-associated macrophages, and MUM-1 expression in follicular lymphoma treated before and after the introduction of monoclonal antibody therapy: a Southwest Oncology Group Study. Ann Oncol. 2010 Jun;21(6):1196-1202. doi: 10.1093/annonc/mdp460. Epub 2009 Oct 29.

  • Sweetenham JW, Hsi E, Goldman B, et al.: Numbers of lymphoma associated macrophages (LAMS) and regulatory T-cells (Tregs) in follicular lymphoma (FL) patients (pts) treated with and without monoclonal antibody (MoAb)-containing therapy do not correlate with overall survival (OS): a study from the Southwest Oncology Group (SWOG). [Abstract] Blood 110 (11): A-2602, 2007.

    RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

Microarray AnalysisImmunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • John W. Sweetenham, MD

    The Cleveland Clinic

    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

January 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 28, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

http://swog.org/Visitors/Download/Policies/Policy43.pdf