S8809-S9800-S9911-S9704-A Study of Blood and Tissue Sampl... | NCT00933127

Studies
S8809-S9800-S9911-S9704-A Study of Blood and Tissue Samples From Patients With Follicular Lymphoma Treated With Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone

NCT00933127

Sponsor

SWOG Cancer Research Network

Status

Completed

Last Update Posted

Jul 24, 2014Estimated

Enrollment

142Actual

Phase

Not provided

Conditions

Lymphoma

Interventions

DNA analysis
polymerase chain reaction
polymorphism analysis
laboratory biomarker analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
SWOG-S8809-S9800-S9911-S9704-A

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jul 3, 2009

First Submission Date that Met QC Criteria

Jul 3, 2009

First Posted Date

Jul 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2014

Last Update Posted Date

Jul 24, 2014Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood and tissue samples from patients with follicular lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone.

Detailed Description

OBJECTIVES:

To test for association of polymorphisms in Fc-gamma (Fcγ) receptors IIa (H/R131) and IIIa (V/F158) with progression-free survival and clinical response in patients with follicular non-Hodgkin lymphoma treated with rituximab and CHOP chemotherapy comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone.
To assess novel polymorphisms in Fcγ receptors for predictive and prognostic significance in patients treated with this regimen.

OUTLINE: Genomic DNA extracted from paired samples of serum and formalin-fixed paraffin-embedded tissue is analyzed for R131H polymorphism in Fcγ receptor IIa and V158F polymorphism in Fcγ receptor IIIa by TaqMan-based assay. The DNA is also analyzed for genotypes corresponding with several other polymorphisms in Fcγ receptors, as determined by the HapMap project. The resulting Fcγ receptor genotypes are then compared with clinical data from the Southwest Oncology Group database to identify associations between particular genotypes and progression-free survival, overall response, and complete response. A multivariate analysis incorporating clinical prognostic variables (e.g., age, stage, serum LDH level, extranodal disease, and performance status) is also performed to determine whether Fcγ receptor polymorphisms are independent predictive or prognostic markers for clinical outcome.

Conditions Module

Conditions

Lymphoma

Keywords

contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association of Fc-gamma (Fcγ) receptor genotypes with overall and/or progression-free survival and clinical response		retrospectively
Novel polymorphisms in Fcγ receptors for predictive and prognostic significance		retrospectively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of follicular lymphoma
Meets either of the following criteria:
- Previously enrolled on clinical trial SW0G-8809 and treated with chemotherapy alone
  - Excess tissue sections available
- Previously enrolled on clinical trial SWOG-9800 or SWOG-9911 and treated with a combination of chemotherapy and monoclonal antibody therapy
Matched serum and tissue samples available from the SWOG Lymphoma Bank

PATIENT CHARACTERISTICS:

See Disease Characteristics

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients enrolled to S8809 S9800 S9911 S9704 consenting to banking

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Lisa Rimsza, MD	University of Arizona	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22271896	Result	Persky DO, Dornan D, Goldman BH, Braziel RM, Fisher RI, Leblanc M, Maloney DG, Press OW, Miller TP, Rimsza LM. Fc gamma receptor 3a genotype predicts overall survival in follicular lymphoma patients treated on SWOG trials with combined monoclonal antibody plus chemotherapy but not chemotherapy alone. Haematologica. 2012 Jun;97(6):937-42. doi: 10.3324/haematol.2011.050419. Epub 2012 Jan 22.

ID	Term
D008223	Lymphoma
D008224	Lymphoma, Follicular

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D008228	Lymphoma, Non-Hodgkin

ID	Term
D016133	Polymerase Chain Reaction
D054458	Amplified Fragment Length Polymorphism Analysis

ID	Term
D021141	Nucleic Acid Amplification Techniques
D005821	Genetic Techniques
D008919	Investigative Techniques
D016172	DNA Fingerprinting

Name	Type	Description	Arm Group Labels	Other Names
DNA analysis	Genetic
polymerase chain reaction	Genetic
polymorphism analysis	Genetic
laboratory biomarker analysis	Other