Light-Scattering Spectroscopy for Detection of Breast Cancer | NCT01755208

Studies
Light-Scattering Spectroscopy for Detection of Breast Cancer

NCT01755208

Sponsor

University of Southern California

Status

Terminated

Last Update Posted

Nov 19, 2021Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Healthy, no Evidence of Disease
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer

Interventions

light-scattering spectroscopy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2012-02769	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient Accrual

Expanded Access Info

Start Date

Nov 21, 2012Actual

Primary Completion Date

Nov 19, 2020Actual

Completion Date

Nov 19, 2020Actual

First Submitted Date

Dec 18, 2012

First Submission Date that Met QC Criteria

Dec 18, 2012

First Posted Date

Dec 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2021

Last Update Posted Date

Nov 19, 2021Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic (light-scattering spectroscopy)	Experimental	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.	Procedure: light-scattering spectroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
light-scattering spectroscopy	Procedure	Undergo light-scattering spectroscopy	Diagnostic (light-scattering spectroscopy)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accurate classifications of women with or without breast cancer	Exact binomial probabilities will be used.	Up to 1 year
Utility of optical markers in distinguishing cancer involved breasts from normal breasts	Multivariate analyses will be used.	Up to 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacques Van Dam	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USC Norris Comprehensive Cancer Center		Los Angeles	California	90033	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided