S8516-S8736-S9125-S9240 Research Study of Genes in Tissue... | NCT00985699

Studies
S8516-S8736-S9125-S9240 Research Study of Genes in Tissue Samples From Patients With B-cell Non-Hodgkin Lymphoma

NCT00985699

Sponsor

SWOG Cancer Research Network

Status

Completed

Last Update Posted

Jul 24, 2014Estimated

Enrollment

337Actual

Phase

Not provided

Conditions

Lymphoma

Interventions

polymorphism analysis
laboratory biomarker analysis
pharmacogenomic studies

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SWOG-S8516-S8736-S9125-S9240-S	Other Identifier	SWOG
U10CA032102	U.S. NIH Grant/Contract		View source

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

Apr 2009

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Sep 25, 2009

First Submission Date that Met QC Criteria

Sep 25, 2009

First Posted Date

Sep 28, 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 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.

PURPOSE: This research study is looking at genes in tissue samples from patients with B-cell non-Hodgkin lymphoma.

Detailed Description

OBJECTIVES:

To determine if toxicity following treatment for lymphoma varies according to genetic polymorphisms in oxidative stress-related genes (i.e., SOD2, CAT, GPX1, GSTM1, and GSTP1).
To assess whether these genetic polymorphisms are associated with progression-free survival and/or overall survival in these patients treated for lymphoma.

OUTLINE: Previously collected samples are used for biomarker analysis.

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

337Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association of polymorphisms in oxidative stress-related genes with overall survival and/or progression-free survival		retrospectively
Association of polymorphisms in these genes with rate of grade 4-5 hematologic toxicity		retrospectively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of aggressive B-cell non-Hodgkin lymphoma
- Previously treated with curative intent using anthracycline-based therapies
Previously collected paraffin-embedded diagnostic tissues from clinical trials that were collected as part of SWOG treatment protocols (S8516, S8736, S9125, S9240, and S9349) available

PATIENT CHARACTERISTICS:

Not specified

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 on S8516 S8736 S9125 S9240 consenting to banking

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Margaret M. Briehl, PhD	University of Arizona	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma
D008228	Lymphoma, Non-Hodgkin
D018442	Lymphoma, B-Cell, Marginal Zone

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054458	Amplified Fragment Length Polymorphism Analysis
D000071185	Pharmacogenomic Testing

Ancestor Terms

ID	Term
D016172	DNA Fingerprinting
D005821	Genetic Techniques
D008919	Investigative Techniques
D016133	Polymerase Chain Reaction

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
polymorphism analysis	Genetic
laboratory biomarker analysis	Other
pharmacogenomic studies	Other