Breast CancerNCT01431872
Systemic Dickkopf-related Protein 1 (DKK1)During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors
An observational study of Breast Cancer, run by University of Arkansas at 1 site in United States.
Trial summary
The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to peak, then decrease gradually as estrogens reach a new lower, but steady level. The investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion from the osteoblastogenic pathway to the… 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
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2015
- 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: Post menopausal breast cancer patients who are planning to be treated with aromatase inhibitors.
Who may be able to join
- Post Menopausal Breast cancer patients with planned treatment of aromatase inhibitors.
- 18 years or older
Who cannot join
- BMI >30 or <18
- Osteoporosis as defined by protocol.
- Subjects currently on bisphosphonate therapy.
- History of primary or secondary hyperparathyroidism
- History of Hypo-or Hyperthyroidism
- History of Vitamin D levels below LLN
Show all 11Show fewer
- History of creatinine clearance below the EGFR
- History ofLiver function tests above 1.5 times ULN including LDH, SGOT, SGPT, Alkaline phosphatase, and Bilirubin
- History of documented cirrhosis of the liver
- History of chronic heparin use
- History of chronic glucocorticoid therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72120
About this study
Official title: Systemic DKK1 During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors
The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to peak, then decrease gradually as estrogens reach a new lower, but steady level. The investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion from the osteoblastogenic pathway to the adipogenic pathway.
The investigators will conduct a longitudinal cohort study of post menopausal women with hormone-responsive breast cancer that will be treated AIs. The study will observe anthromorphic and serum marker changes during the first year of their treatment.
- Conditions
- Breast Cancer
- Keywords
- Aromatase Inhibitors
- 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 |
|---|---|---|
| Post menopausal breast cancer patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estrogen level suppresses DKK1
With the start of AI treatment, estrogen levels will decline to almost undetectable levels. We believe this decrease in estrogen will lift suppression of DKK1 and allow its expression to peak during the 1st month of treatment, and decline more slowly thereafter. During the first 26 weeks of treatment, we expect levels of CTx to rise, PTH to fall, and P1NP to show no change, findings that would be consistent with Heshmati's study.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2015
- Study completionAug 2015
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Hutchins, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431872
- Sponsor's protocol ID
- 131471
- Status last verified
- Nov 2015
- First submitted
- 8 Sep 2011
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic DKK1 During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT01431872
- Acronym / sponsor ID
- 131471
- Conditions
- Breast Cancer
- Keywords
- Aromatase Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Sep 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.
The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to peak, then decrease gradually as estrogens reach a new lower, but steady level. The investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion from the osteoblastogenic pathway to the adipogenic pathway.
The investigators will conduct a longitudinal cohort study of post menopausal women with hormone-responsive breast cancer that will be treated AIs. The study will observe anthromorphic and serum marker changes during the first year of their treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post menopausal breast cancer patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post menopausal breast cancer patients who are planning to be treated with aromatase inhibitors.
Key inclusion criteria (2 listed)
- Post Menopausal Breast cancer patients with planned treatment of aromatase inhibitors.
- 18 years or older
Key exclusion criteria (11 listed)
- BMI >30 or <18
- Osteoporosis as defined by protocol.
- Subjects currently on bisphosphonate therapy.
- History of primary or secondary hyperparathyroidism
- History of Hypo-or Hyperthyroidism
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
Estrogen level suppresses DKK1
Time frame: 26 weeks
With the start of AI treatment, estrogen levels will decline to almost undetectable levels. We believe this decrease in estrogen will lift suppression of DKK1 and allow its expression to peak during the 1st month of treatment, and decline more slowly thereafter. During the first 26 weeks of treatment, we expect levels of CTx to rise, PTH to fall, and P1NP to show no change, findings that would be consistent with Heshmati's study.
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 4 Nov 2015.
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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.
Laura Hutchins, MD principal investigator
University of Arkansas
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 Arkansas 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 2 inclusion and 11 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 4 Nov 2015. 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?
Estrogen level suppresses DKK1 (time frame: 26 weeks). 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 4 Nov 2015.