Arthralgia SyndromeCIRASNCT00890058
A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome
An observational study of Arthralgia Syndrome and Arthritis, run by Victoria Shanmugam at 1 site in United States.
Trial summary
The CIRAS study will investigate postmenopausal breast cancer patients with hand pain and compare those receiving aromatase inhibitors (cases) to breast cancer patients with hand pain not receiving aromatase inhibitors (controls) in order assess whether this syndrome is an inflammatory arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Arthralgia Syndrome, Arthritis, Synovitis
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2010
- 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: Postmenopausal women with stage I-III breast cancer currently undergoing treatment at the Lombardi Cancer Center will be screened for the presence of joint and hand symptoms.Patients with symptoms who are receiving aromatase inhibitors will be considered to be cases, while those with symptoms who are not receiving aromatase inhibitors will be considered to be controls.
Who may be able to join
- Postmenopausal women aged over 18 with stage I-III breast cancer undergoing treatment at the Lombardi Cancer Center.
- Presence of hand pain
- No active signs of ongoing malignant disease
Who cannot join
- Known autoimmune disease for example, rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, or seronegative arthritis.
- Age <18
- Unable to complete informed consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
The CIRAS study will investigate postmenopausal breast cancer patients with hand pain and compare those receiving aromatase inhibitors (cases) to breast cancer patients with hand pain not receiving aromatase inhibitors (controls) in order assess whether this syndrome is an inflammatory arthritis.
Read the detailed description
This study is for women with post-menopausal breast cancer and hand pain. Patients do not need to be taking aromatase inhibitors to be eligible for the study. We want to study the joint findings in patients with hand pain and breast cancer undergoing treatment with aromatase inhibitor medications and compare them to patients with hand pain and breast cancer not treated with these medications.
Aromatase inhibitor drugs are used in certain types of breast cancer to reduce the risk of cancer returning after treatment. One of the side effects of aromatase inhibitors is the development of joint pain, a complication known as the Arthralgia Syndrome. The cause of the Arthralgia Syndrome is not known, but we suspect that the pain may be due to inflammation in the joints. Currently, the only effective treatment is to stop the aromatase inhibitor, and so affected patients may miss out on an otherwise useful treatment to prevent return of their cancer.
Post-menopausal patients with breast cancer and hand pain can enroll in the study. Patients will be asked to come for a separate visit which will take about half a day.
- Conditions
- Arthralgia Syndrome, Arthritis, Synovitis
- Keywords
- Arthritis, Synovitis, Aromatase Inhibitor, Arthralgia Syndrome
- Medical subject headings
- Arthritis, Synovitis
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 |
|---|---|---|
| Cases | Postmenopausal breast cancer patients with hand pain receiving aromatase inhibitors | |
| Controls | Postmenopausal breast cancer patients with hand pain not receiving aromatase inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in DAS-28 between cases and controls
Measured: 1 year
Secondary outcomes (1)
Differences between cases and controls in mean ESR, TNF-alpha, IL-6 and ultrasound measurement of tenosynovitis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthralgia SyndromeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victoria Shanmugam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Victoria Shanmugam, George Washington University
- Investigators
- Victoria Shanmugam, MD, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890058
- Sponsor's protocol ID
- 2008-547
- Acronym
- CIRAS
- Status last verified
- Aug 2016
- First submitted
- 27 Apr 2009
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shanmugam VK, McCloskey J, Elston B, Allison SJ, Eng-Wong J. The CIRAS study: a case control study to define the clinical, immunologic, and radiographic features of aromatase inhibitor-induced musculoskeletal symptoms. Breast Cancer Res Treat. 2012 Jan;131(2):699-708. doi: 10.1007/s10549-011-1849-8. Epub 2011 Nov 11.
PubMed 22076476
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome
- ClinicalTrials.gov ID
- NCT00890058
- Acronym / sponsor ID
- CIRAS / 2008-547
- Conditions
- Arthralgia Syndrome, Arthritis, Synovitis
- Keywords
- Arthritis, Synovitis, Aromatase Inhibitor, Arthralgia Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Victoria ShanmugamUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Apr 2009 (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 CIRAS study will investigate postmenopausal breast cancer patients with hand pain and compare those receiving aromatase inhibitors (cases) to breast cancer patients with hand pain not receiving aromatase inhibitors (controls) in order assess whether this syndrome is an inflammatory arthritis.
Detailed description
This study is for women with post-menopausal breast cancer and hand pain. Patients do not need to be taking aromatase inhibitors to be eligible for the study. We want to study the joint findings in patients with hand pain and breast cancer undergoing treatment with aromatase inhibitor medications and compare them to patients with hand pain and breast cancer not treated with these medications.
Aromatase inhibitor drugs are used in certain types of breast cancer to reduce the risk of cancer returning after treatment. One of the side effects of aromatase inhibitors is the development of joint pain, a complication known as the Arthralgia Syndrome. The cause of the Arthralgia Syndrome is not known, but we suspect that the pain may be due to inflammation in the joints. Currently, the only effective treatment is to stop the aromatase inhibitor, and so affected patients may miss out on an otherwise useful treatment to prevent return of their cancer.
Post-menopausal patients with breast cancer and hand pain can enroll in the study. Patients will be asked to come for a separate visit which will take about half a day.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Postmenopausal breast cancer patients with hand pain receiving aromatase inhibitors |
| Controls | – | –Postmenopausal breast cancer patients with hand pain not receiving aromatase inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with stage I-III breast cancer currently undergoing treatment at the Lombardi Cancer Center will be screened for the presence of joint and hand symptoms.Patients with symptoms who are receiving aromatase inhibitors will be considered to be cases, while those with symptoms who are not receiving aromatase inhibitors will be considered to be controls.
Key inclusion criteria (3 listed)
- Postmenopausal women aged over 18 with stage I-III breast cancer undergoing treatment at the Lombardi Cancer Center.
- Presence of hand pain
- No active signs of ongoing malignant disease
Key exclusion criteria (3 listed)
- Known autoimmune disease for example, rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, or seronegative arthritis.
- Age <18
- Unable to complete informed consent process
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
Difference in DAS-28 between cases and controls
Time frame: 1 year
1 secondary outcome
Differences between cases and controls in mean ESR, TNF-alpha, IL-6 and ultrasound measurement of tenosynovitis.
Time frame: 1 year
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 30 Aug 2016.
- Derived from this study: PubMed 22076476Shanmugam VK, McCloskey J, Elston B, Allison SJ, Eng-Wong J. The CIRAS study: a case control study to define the clinical, immunologic, and radiographic features of aromatase inhibitor-induced musculoskeletal symptoms. Breast Cancer Res Treat. 2012 Jan;131(2):699-708. doi: 10.1007/s10549-011-1849-8. Epub 2011 Nov 11.
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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.
Victoria Shanmugam, MD principal investigator
Georgetown University Hospital
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 Arthralgia Syndrome and Arthritis, run by Victoria Shanmugam 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 3 inclusion and 3 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 30 Aug 2016. 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?
Difference in DAS-28 between cases and controls (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00890058, which also lists 1 linked publication.
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 30 Aug 2016.