Breast CancerNCT01341171
The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Proteins
An observational study of Breast Cancer, run by University of Vermont at 1 site in United States.
Trial summary
Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women using tamoxifen or aromatase inhibitor therapy for greater than 6 months
Who may be able to join
- women routinely taking tamoxifen or aromatase inhibitor therapy as prescribed by their oncologist
Who cannot join
- Use of heparin, warfarin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Modulation in the Control of Angiogenesis: The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Activation and Angiogenic Proteins
Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.
- Conditions
- Breast Cancer
- Keywords
- tamoxifen, aromatase inhibitors, breast cancer, platelets
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| tamoxifen or aromatase inhibitors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiogenic Protein levels
Measured: following 6 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startAug 2009
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Chris Holmes, University of Vermont
- Investigators
- Chris E Holmes, MD, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341171
- Sponsor's protocol ID
- V0805
- Status last verified
- Sep 2020
- First submitted
- 7 Jul 2010
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Modulation in the Control of Angiogenesis: The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Activation and Angiogenic Proteins
- ClinicalTrials.gov ID
- NCT01341171
- Acronym / sponsor ID
- V0805
- Conditions
- Breast Cancer
- Keywords
- tamoxifen, aromatase inhibitors, breast cancer, platelets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Aug 2009
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 25 Apr 2011 (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.
Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tamoxifen or aromatase inhibitors | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women using tamoxifen or aromatase inhibitor therapy for greater than 6 months
Key inclusion criteria (1 listed)
- women routinely taking tamoxifen or aromatase inhibitor therapy as prescribed by their oncologist
Key exclusion criteria (1 listed)
- Use of heparin, warfarin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Angiogenic Protein levels
Time frame: following 6 months of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
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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.
Chris E Holmes, MD, PhD principal investigator
University of Vermont
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 Breast Cancer, run by University of Vermont 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Sep 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Angiogenic Protein levels (time frame: following 6 months of therapy). 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 17 Sep 2020.