Using Bio Markers to Predict Disease Recurrence and Cognitive Function in High Risk Breast Ca

NCT00756132 | Completed

• 1 other identifier: BernLCyto-Cog
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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 thinking abilities. The causes of these declines are not known. However, we know that (i) people with cancer may have high levels of molecules in the blood (cytokines) that reflect inflammation; (ii) injection of cytokines into animals, and their use to treat some human diseases, can lead to decreased memory and attention; and (iii) in some advanced cancers cytokines predict disease outcome. This longitudinal study evaluates the relation of cytokines to decreased thinking abilities and to disease outcome over time. Results of this study may help develop interventions to prevent or minimize cognitive decline and identify women who are at high risk for recurrence, and such information could be used in treatment decisions and in the development of new treatment options.

Conditions

Locally Advanced Breast Cancer; Breast Cancer

Keywords

Breast; Neoplasm; Locally Advanced; Stage IV; Stage III; Cognitive Function; Cytokines; Inflammatory; Node positive

Outcome Measures

Primary Outcomes (1)

• Cognitive performance expressed by raw scores, T and Z scores

  2 years

Study Arms (4)

Bloods Only (B)

Women aged 18-65 years with a newly diagnosed locally advanced or high risk operable breast cancer

A-Cog

Women aged 18-65 years newly diagnosed with LABC/high risk who are willing and able to complete cognitive testing.

Control (C)

Healthy women aged 18-65 years who are willing and able to complete cognitive testing.

A1-Cog

Women newly diagnosed locally advanced or high risk breast cancer that qualify for cognitive testing but have a condition related to elevated serum levels of cytokines or other inflammatory markers.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women ages 18-65 with a newly diagnosed locally advanced breast cancer and healthy women ages 18-65.

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lori Bernstein, PhD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

• Bostjan Seruga, MD

  PMH UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

CA (1)