A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome
CIRAS
1 other identifier
observational
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedAugust 30, 2016
August 1, 2016
1.1 years
April 27, 2009
August 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in DAS-28 between cases and controls
1 year
Secondary Outcomes (1)
Differences between cases and controls in mean ESR, TNF-alpha, IL-6 and ultrasound measurement of tenosynovitis.
1 year
Study Arms (2)
Cases
Postmenopausal breast cancer patients with hand pain receiving aromatase inhibitors
Controls
Postmenopausal breast cancer patients with hand pain not receiving aromatase inhibitors
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Known autoimmune disease for example, rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, or seronegative arthritis.
- Age \<18
- Unable to complete informed consent process
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Related Publications (1)
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.
PMID: 22076476DERIVED
Biospecimen
Blood samples for cytokine measurements
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria Shanmugam, MD
Georgetown University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 29, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
August 30, 2016
Record last verified: 2016-08