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

NCT ID: NCT01975597

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-11-19

Brief Summary

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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

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Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Bone marrow aspirates and biopsy

Bone marrow aspirates and biopsy

Intervention Type PROCEDURE

Interventions

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Bone marrow aspirates and biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Van Poznak, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00075575

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2013.053

Identifier Type: -

Identifier Source: org_study_id

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