Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

NCT00500383 | Completed

• 2 other identifiers: UHNREB#07-0689-CEHC#124313
• Study Type: observational
• Target: 372
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to evaluate if a light based technique, called Optical Breast Spectroscopy (OBS) formerly known as Transillumination Breast Spectroscopy (TiBS), can be used to detect differences in breast tissue between high- and low-risk populations and within the high-risk population between BrCa1 or 2 carriers and non-carriers. These differences may include differences in breast tissue composition and metabolism at time of enrollment into the study (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue change over time (possibly reflecting rate of tissue transformation from normal to ultimately malignant state).

Conditions

Breast Cancer

Keywords

Breast Cancer Risk; BRCA1; BRCA2; Breast Cancer Susceptibility gene; Optical Transillumination Spectroscopy; Transillumination Breast Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Difference in rate of change between the high risk groups and the respective controls

  the primary optical measurements are utilized to determine principal component scores in the analysis which in turn will be used as time dependent variable in a linear regression analysis to determine the rate of change.

  over the 4 year duration of the study

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cases are recruited from three participating high-risk screening centres: Familial Breast and Ovarian Cancer Programs at Mount Sinai Hospital and/or Princess Margaret Hospital (Toronto, Ontario, Canada), the Juravinski Cancer Center (Hamilton, Ontario, Canada) and Women's College Hsopital (toronto, Ontario, Canada). Controls are recruited from the respective geographical locations.

You may qualify if:

• BrCa carriers (cases)
• Attending one of the three participating high-risk screening centres
• Confirmed BrCa1 or BrCa2 mutation status through genetic testing
• High-Risk (cases)
• Attending one of the three participating high-risk screening centres
• Confirmed negative BrCa1/2 status through genetic testing
• BrCa non-carriers (controls)
• Attain a GAIL model score of \<1.1 and have \<10% risk of carrying the BRCa mutation Determined by the Penn II model)
• Controls from high-risk screening centre with confirmed BrCa1/2 negative status through genetic testing
• Preference will be given to sisters or first degree cousins of BrCa carriers

You may not qualify if:

• Cases and Controls
• Prior diagnosis or Breast or Ovarian Cancer
• Bilateral biopsy or fine needle aspiration within 1 year of study start
• Bilateral mastectomy, lumpectomy or cosmetic alteration (reduction/augmentation)
• Previous or current chemotherapy or prevention therapy (Tamoxifen)
• Less than 3 years post pregnancy at study start
• inability to provide informed consent due to language or cognitive difficulties
• \*For controls only
• Family history of breast cancer where family member had an early diagnosis (before age 45 years)
• Family history or ovarian cancer

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Mount Sinai Hospital, Canada: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (4)

Juravinski Cancer Center, Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

Related Publications (4)

• Blyschak K, Simick M, Jong R, Lilge L. Classification of breast tissue density by optical transillumination spectroscopy: optical and physiological effects governing predictive value. Med Phys. 2004 Jun;31(6):1398-414. doi: 10.1118/1.1738191.

  PMID: 15259643 BACKGROUND

• Simick MK, Jong R, Wilson B, Lilge L. Non-ionizing near-infrared radiation transillumination spectroscopy for breast tissue density and assessment of breast cancer risk. J Biomed Opt. 2004 Jul-Aug;9(4):794-803. doi: 10.1117/1.1758269.

  PMID: 15250768 BACKGROUND

• Blackmore KM, Knight JA, Jong R, Lilge L. Assessing breast tissue density by transillumination breast spectroscopy (TIBS): an intermediate indicator of cancer risk. Br J Radiol. 2007 Jul;80(955):545-56. doi: 10.1259/bjr/26858614. Epub 2007 May 30.

  PMID: 17537757 BACKGROUND

• Simick MK, Lilge L. Optical transillumination spectroscopy to quantify parenchymal tissue density: an indicator for breast cancer risk. Br J Radiol. 2005 Nov;78(935):1009-17. doi: 10.1259/bjr/14696165.

  PMID: 16249602 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lothar Lilge, PhD

  Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9

  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: July 10, 2007
• First Posted: July 12, 2007
• Study Start: October 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

CA (4)