Studying Tumor Samples From Women Who Have Undergone Chem... | NCT00897845

Studies
Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer

NCT00897845

Sponsor

ECOG-ACRIN Cancer Research Group

Status

Completed

Last Update Posted

May 17, 2017Actual

Enrollment

2,541Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

RNA analysis
microarray analysis
immunohistochemistry staining method
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

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
ECOG-E2197B-ICSC
E2197T2	Other Identifier	ECOG-ACRIN Cancer Research Group

Status Module

Record Verification Date

May 2017

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

Jun 17, 2008Actual

Primary Completion Date

Dec 2, 2013Actual

Completion Date

Dec 2, 2013Actual

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 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

May 16, 2017

Last Update Posted Date

May 17, 2017Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

RATIONALE: Studying samples of tumor 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 tumor samples from women who have undergone chemotherapy for breast cancer.

Detailed Description

OBJECTIVES:

Primary

To identify gene sets for risk of recurrence using molecular profiling in samples from women with lymph node-positive or high-risk lymph node-negative breast cancer on clinical trial ECOG-E2197.

Secondary

To define a set of significant genes as prognostic markers of recurrence.
To compare the prognostic value of the Oncotype DX™ (ODX) 21 gene assay of clinical trial with gene sets determined in this study.
To compare the DASL™ assay of the ODX 21 genes with ODX assay results of clinical trial.
To compare the prognostic value of selected genes with gene sets determined in this study.

OUTLINE: This is a multicenter study.

Samples are used in molecular profiling by applying a custom panel of breast cancer-related genes to a cDNA-mediated Annealing, Selection, Extension, and Ligation (DASL™) assay, immunohistochemistry, and other studies.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

2,541Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RNA analysis	Genetic
microarray analysis	Genetic
immunohistochemistry staining method	Other
laboratory biomarker analysis	Other

Measure	Description	Time Frame
Correlation of results with Outcome		1 month

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer tumor samples collected on clinical trial ECOG-E2197
Histologically lymph node-positive (N1-3) OR high-risk lymph node-negative disease
Hormone receptor-positive or negative disease (status known)
HER2 status known

PATIENT CHARACTERISTICS:

Menopausal status not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Samples submitted for research from patients enrolled on E2197

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Brian Leyland-Jones, MD	Emory University	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D046228	Microarray Analysis
D007150	Immunohistochemistry

Ancestor Terms

ID	Term
D046208	Microchip Analytical Procedures
D008919	Investigative Techniques
D006651	Histocytochemistry
D003584	Cytological Techniques

Browse Leaves

Not provided

Browse Branches

Not provided