- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01975597
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
-
-
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
|
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.
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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