Protocol for Postmenopausal Women at Increased Risk of De... | NCT00329017

Studies
Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

NCT00329017

Sponsor

Carol Fabian, MD

Status

Withdrawn

Last Update Posted

Oct 10, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Fine needle aspiration

Countries

United States

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

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Nov 12, 2015Actual

Completion Date

Nov 12, 2015Actual

First Submitted Date

May 19, 2006

First Submission Date that Met QC Criteria

May 19, 2006

First Posted Date

May 24, 2006Estimated

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

Oct 7, 2019

Last Update Posted Date

Oct 10, 2019Actual

Name	Class
Intergenetics, Inc.	INDUSTRY

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

A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.

Detailed Description

A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.

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

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Post-menopausal women who are at increased risk for development of breast cancer on the basis of family or personal history.	Procedure: Fine needle aspiration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fine needle aspiration	Procedure	Fine needle aspiration	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of SNP patterns with cytlomorphology of breast fine needle aspirates.	develoment of algorithm for prediction of risk of developing breast cancer.	ongoing

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

postmenopausal women on or off hormone replacement therapy
at high risk of developing breast cancer determined by family or personal history
postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration
willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion Criteria:

women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Post menopausal women, on or off hormone replacement therapy, at high risk of developing breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol J Fabian, MD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Global results will be published.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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
D044963	Biopsy, Fine-Needle

Ancestor Terms

ID	Term
D001707	Biopsy, Needle
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques

Browse Leaves

Not provided

Browse Branches

Not provided