Identification of Biomarkers in Women at High Risk or Ave... | NCT00897416

Studies
Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer

NCT00897416

Sponsor

Fred Hutchinson Cancer Center

Status

Completed

Last Update Posted

Nov 9, 2010Estimated

Enrollment

1,452Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

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
FHCRC-5518
CDR0000355401	Registry Identifier	PDQ

Status Module

Record Verification Date

Nov 2010

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

Oct 2001

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

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

Nov 5, 2010

Last Update Posted Date

Nov 9, 2010Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

RATIONALE: Collecting and storing samples of blood and studying them in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is examining biomarkers in women with a high risk or average risk of breast cancer.

Detailed Description

OBJECTIVES:

Primary

Identify and validate serum biomarkers that can distinguish malignant from benign and normal breast conditions in women at high risk or average risk for breast cancer.

Secondary

Standardize procedures for recruitment, characterization, and follow-up of participants and collection, processing, storage, and analysis of specimens.
Assess marker variability over time in healthy controls.
Develop a shared specimen resource to support ongoing early detection research.

OUTLINE: Blood samples are collected every 6 months and assayed for the presence of biomarkers.

PROJECTED ACCRUAL: A total of 625 participants will be accrued for this study.

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

1,452Actual

Name	Type	Description	Arm Group Labels	Other Names
laboratory biomarker analysis	Other

Measure	Description	Time Frame
Biomarker evaluation for the early detection of breast cancer to improve outcomes for women at risk for breast cancer

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Planning to undergo outpatient annual mammogram or biopsy AND meets 1 of the following criteria:
- High risk for breast cancer
- High risk with newly-diagnosed* breast cancer
- Average risk for breast cancer
- Average risk with newly-diagnosed* breast cancer
- Benign breast disease NOTE: * Diagnosed at time of study enrollment
No other breast cancer diagnosis within the past year
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

25 and over

Sex

Female

Menopausal status

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

No hemophilia
No other bleeding disorders

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
At least 6 months postpartum
No planned pregnancy within the next year
No history of medical conditions that would increase participant risk of blood draws
No psychiatric, psychological, or other condition that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

No prior double mastectomy

Other

No concurrent treatment for breast cancer

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy women undergoing screening mammography or breast biopsy.

Sampling Method

Non-Probability Sample

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