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

August 30, 2023 updated by: University of Michigan Rogel Cancer Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bone marrow aspirates and biopsy
Procedure: Bone marrow aspirates and biopsy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Catherine Van Poznak, MD, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

November 19, 2014

Study Completion (Actual)

November 19, 2014

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimated)

November 3, 2013

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2013.053
  • HUM00075575 (Other Identifier: University of Michigan)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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