Healthy, no Evidence of DiseaseNCT01755208
Light-Scattering Spectroscopy for Detection of Breast Cancer
A study testing light-scattering spectroscopy in people with Healthy, no Evidence of Disease and Stage II Breast Cancer, run by University of Southern California at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease, Stage II Breast Cancer, Stage IIIA Breast Cancer
- What is being tested?
- light-scattering spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2012to 19 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy, no Evidence of Disease, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Being tested
- light-scattering spectroscopy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light-scattering spectroscopyProcedure or surgery
Undergo light-scattering spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: light-scattering spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate classifications of women with or without breast cancer
Exact binomial probabilities will be used.
Measured: Up to 1 year
Utility of optical markers in distinguishing cancer involved breasts from normal breasts
Multivariate analyses will be used.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study start21 Nov 2012
- Primary completion19 Nov 2020
- Study completion19 Nov 2020
Why it stopped: Insufficient Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jacques Van Dam, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755208
- Sponsor's protocol ID
- 1B-12-6
- Other IDs
- NCI-2012-02769
- Status last verified
- Nov 2021
- First submitted
- 18 Dec 2012
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT01755208
- Acronym / sponsor ID
- 1B-12-6
- Conditions
- Healthy, no Evidence of Disease, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Accrual
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Nov 2012 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (light-scattering spectroscopy) | Experimental | Procedure: light-scattering spectroscopyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| light-scattering spectroscopyUndergo light-scattering spectroscopy | Procedure or surgery | Diagnostic (light-scattering spectroscopy) |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Van Dam principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing light-scattering spectroscopy in people with Healthy, no Evidence of Disease and Stage II Breast Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate classifications of women with or without breast cancer (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.