Metastatic Breast CancerNCT01975597
Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Bone marrow aspirates and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 19 Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Bone marrow aspirates and biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow aspirates and biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow aspirates and biopsy | Not described Receives: Procedure: Bone marrow aspirates and biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient that agree to undergo 2 biopsy's strictly for research purposes.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startAug 2013
- Primary completion19 Nov 2014
- Study completion19 Nov 2014
Why it stopped: held for blocking amendment then determined not to re-open
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Van Poznak, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975597
- Sponsor's protocol ID
- UMCC 2013.053
- Other IDs
- HUM00075575
- Status last verified
- Aug 2023
- First submitted
- 3 Sep 2013
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01975597
- Acronym / sponsor ID
- UMCC 2013.053
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: held for blocking amendment then determined not to re-open
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 19 Nov 2014 (actual)
- Study completion
- 19 Nov 2014 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone marrow aspirates and biopsy | – | Procedure: Bone marrow aspirates and biopsy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow aspirates and biopsy | Procedure or surgery | Bone marrow aspirates and biopsy |
Primary outcome
Number of patient that agree to undergo 2 biopsy's strictly for research purposes.
Time frame: At 3 months
Results and safety
The study was stopped early (reason given: held for blocking amendment then determined not to re-open). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Van Poznak, MD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: held for blocking amendment then determined not to re-open). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient that agree to undergo 2 biopsy's strictly for research purposes. (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.