Status:
COMPLETED
Using Bio Markers to Predict Disease Recurrence and Cognitive Function in High Risk Breast Ca
Lead Sponsor:
University Health Network, Toronto
Conditions:
Locally Advanced Breast Cancer
Breast Cancer
Eligibility:
FEMALE
18-65 years
Brief Summary
Women with breast cancer undergo treatments that decrease the chance of recurrence of cancer, but are associated with several side effects, including declines in memory and attention and other thinkin...
Detailed Description
SCIENTIFIC ABSTRACT Background: Women with locally advanced breast cancer (LABC), and women with high risk (T2-3/N+4, triple negative) yet operable breast cancer, undergo combined treatment including ...
Eligibility Criteria
Inclusion
- (i) women age 18-65, (ii) for group A: women with histologically confirmed invasive breast cancer that is locally advanced (inflammatory and non-inflammatory LABC - any T3-T4 M0 and/or N2-3 M0 stages)
- women 18-65 with histologically confirmed high risk operable breast cancer (T2 and/or N+ M0 endocrine unresponsive breast cancers (ER- and PR-). and HER-2-/+, or any operable breast cancer with ≥ 4 involved axillary lymph nodes
- for group B (healthy controls): healthy women 18-65
Exclusion
- (i) conditions that are associated with elevated serum levels of cytokines and other inflammatory markers (major inflammatory, chronic infectious or autoimmune systemic disease, cardiovascular disease, diabetes mellitus type I and II), or (ii) any concomitant or prior malignant disease. Those recruited for evaluation on cognitive functions will also be excluded for (iii) major pre-existing psychiatric history (including depression), dementia, alcohol abuse, or currently using a psychotropic medication that might lead to cognitive problems, (iv) insufficient English skills to comprehend the task instructions, and (v) impaired colour vision for reasons related to some of the test stimuli and tasks.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00756132
Start Date
August 1 2008
End Date
September 1 2017
Last Update
February 28 2018
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9