Biomarkers in Tissue Samples From Patients With Ductal Br... | NCT01132560

Studies
Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ

NCT01132560

Sponsor

ECOG-ACRIN Cancer Research Group

Status

Completed

Last Update Posted

May 17, 2017Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

RNA analysis
gene expression analysis
reverse transcriptase-polymerase chain reaction
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-E5194T1

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

Mar 5, 2010Actual

Primary Completion Date

Apr 5, 2010Actual

Completion Date

Apr 5, 2010Actual

First Submitted Date

May 26, 2010

First Submission Date that Met QC Criteria

May 26, 2010

First Posted Date

May 28, 2010Estimated

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 studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.

Detailed Description

OBJECTIVES:

To validate the prognostic utility of a new ductal breast carcinoma in situ (DCIS) genomic score and the Oncotype DX Recurrence Score® assay in tissue samples from patients with DCIS enrolled on clinical trial ECOG-E5194.

OUTLINE: RNA extracted from archived tissue samples are analyzed for gene expression profile by Oncotype DX Recurrence Score® assay (a reverse transcriptase-PCR-based assay).

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

500Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RNA analysis	Genetic
gene expression analysis	Genetic
reverse transcriptase-polymerase chain reaction	Genetic
laboratory biomarker analysis	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ipsilateral local failure (first event of invasive or DCIS recurrence)		1 month

Secondary Outcomes

Measure	Description	Time Frame
Contralateral breast cancer (invasive or DCIS)		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of ductal breast carcinoma in situ
Enrolled on clinical trial ECOG-E5194
- Local surgery without radiotherapy
- Treated or not treated with tamoxifen
Available tissue samples
Hormone receptor status not specified

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 patient enrolled on E5194

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence J. Solin, MD, FACR	Abramson Cancer Center at Penn Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D002285	Carcinoma, Intraductal, Noninfiltrating

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
D020869	Gene Expression Profiling
D020133	Reverse Transcriptase Polymerase Chain Reaction

Ancestor Terms

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques
D016133	Polymerase Chain Reaction
D021141	Nucleic Acid Amplification Techniques

Browse Leaves

Not provided

Browse Branches

Not provided