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Light-Scattering Spectroscopy for Detection of Breast Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by University of Southern California
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01755208
First received: December 18, 2012
Last updated: April 11, 2017
Last verified: April 2017
December 18, 2012
April 11, 2017
November 21, 2012
November 21, 2018   (Final data collection date for primary outcome measure)
  • Accurate classifications of women with or without breast cancer [ Time Frame: Up to 1 year ]
    Exact binomial probabilities will be used.
  • Utility of optical markers in distinguishing cancer involved breasts from normal breasts [ Time Frame: Up to 1 year ]
    Multivariate analyses will be used.
Same as current
Complete list of historical versions of study NCT01755208 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Light-Scattering Spectroscopy for Detection of Breast Cancer
Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
This pilot clinical trial studies light-scattering spectroscopy in finding disease in patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering spectroscopy, may help find and diagnose breast cancer

PRIMARY OBJECTIVES: I. To evaluate whether light-scattering spectroscopy can reliably distinguish between two subject groups: those with clinical stage II or stage III breast cancer and those without breast cancer.

OUTLINE: Patients undergo light-scattering spectroscopy of the breast in addition to standard of care as it relates to screening for breast cancer or treatment of breast cancer.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
  • Healthy, no Evidence of Disease
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
Procedure: light-scattering spectroscopy
Undergo light-scattering spectroscopy
Experimental: Diagnostic (light-scattering spectroscopy)
Patients undergo light-scattering spectroscopy of the breast in addition to standard of care as it relates to screening for breast cancer or treatment of breast cancer.
Intervention: Procedure: light-scattering spectroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
November 21, 2019
November 21, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants who are breast cancer free (mammogram "negative" within 1 month of testing) with the absence of clinical suspicion of breast cancer on physical exam or with clinical stage II or stage III breast cancer. PLEASE NOTE: Recruitment for this study is only limited to patients who are scheduled for a mammogram at USC. There is no compensation to participants.
  • Provision of informed consent prior to any study-related procedures

Exclusion Criteria:

  • Females with tattoos on either or both breasts
  • Females with nipple piercings on either or both breasts
  • Females with skin piercings (aka microdermal anchor surface or microdermal piercings) in either or both breasts
  • Females unable to provide informed consent
  • Females s/p treatment for breast cancer
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact: Pui Yan 323-865-3000 Puiyan@med.usc.edu
United States
 
 
NCT01755208
1B-12-6
NCI-2012-02769 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
University of Southern California
University of Southern California
National Cancer Institute (NCI)
Principal Investigator: Jacques Van Dam University of Southern California
University of Southern California
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP