Pilot Study of Bone Biopsy and Aspirate in Women With Met... | NCT01975597

Studies
Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer

NCT01975597

Sponsor

University of Michigan Rogel Cancer Center

Status

Terminated

Last Update Posted

Sep 1, 2023Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Metastatic Breast Cancer

Interventions

Bone marrow aspirates and biopsy

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

ID	Type	Description	Link
HUM00075575	Other Identifier	University of Michigan

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

held for blocking amendment then determined not to re-open

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Nov 19, 2014Actual

Completion Date

Nov 19, 2014Actual

First Submitted Date

Sep 3, 2013

First Submission Date that Met QC Criteria

Oct 28, 2013

First Posted Date

Nov 4, 2013Estimated

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

Aug 30, 2023

Last Update Posted Date

Sep 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is a feasibility study to demonstrate the team's ability to collect bone marrow aspirates and biopsies for research purposes from women with metastatic breast cancer.

Detailed Description

Not provided

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

Retention

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bone marrow aspirates and biopsy			Procedure: Bone marrow aspirates and biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bone marrow aspirates and biopsy	Procedure		Bone marrow aspirates and biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patient that agree to undergo 2 biopsy's strictly for research purposes.		At 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with metastatic breast cancer (any site) age 21 or older
Patients willing and able to provide informed consent & perform study procedures
Patients may enroll with recently (with 2 months) progressive tumor burden
Performance status of 0,1 or 2

Exclusion Criteria:

Patients unable or unwilling to provide informed consent and or perform study procedures
Patients with active, uncontrolled coagulopathy
Patients on treatment dose anticoagulation or an International Normalised Ratio of 2 or greater if on warfarin
Patients who are known to be pregnant are not eligible to participate in this study during the time of the pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who are receiving care for metastatic breast cancer at University of Michigan Rogel Cancer Center will be recruited for this study to donate samples.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Catherine Van Poznak, MD	University of Michigan Rogel Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States

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
D001706	Biopsy

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided