Breast CancerNCT00918788
Laser Spectroscopy of Breast Tissue Through a Needle Device
An observational study of Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Collecting and storing samples of breast tissue from patients who have undergone biopsy or surgery to test in the laboratory may help the study of cancer in the future. PURPOSE: This laboratory study is looking at samples of breast tissue from women who have undergone breast biopsy or surgery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- biologic sample preservation procedure, immunohistochemistry staining method and light microscopy
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2013
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary Care Clinic
DISEASE CHARACTERISTICS:
- Discarded normal and malignant breast tissue surgical specimens from women who have undergone excisional breast biopsy, lumpectomy, mastectomy, or breast-reduction surgery at the University Hospitals-Case Medical Center
- Hormone receptor status unknown
PATIENT CHARACTERISTICS:
- Menopausal status unknown
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
RATIONALE: Collecting and storing samples of breast tissue from patients who have undergone biopsy or surgery to test in the laboratory may help the study of cancer in the future.
PURPOSE: This laboratory study is looking at samples of breast tissue from women who have undergone breast biopsy or surgery.
Read the detailed description
OBJECTIVES:
- To prove that optical spectra collected by inserting an optical fiber probe into breast tissue through a biopsy needle can be of adequate quality to render a spectroscopic diagnosis.
OUTLINE: Optical spectra are acquired from ex vivo samples of normal and malignant breast tissue using diffuse reflectance, fluorescence, and Raman spectroscopy. Tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle. After the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements. The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H\&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
Medical records are reviewed to obtain information from the pathology report on patient demographics, pathological characteristics of the surgical specimen, and clinical indication for the surgical procedure.
- Conditions
- Breast Cancer
- Being tested
- biologic sample preservation procedure, immunohistochemistry staining method, light microscopy, medical chart review, histopathologic examination
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
Ex vivo samples of normal and malignant breast tissue; biopsy specimens are then fixed in formalin and submitted for histopathologic studies
immunohistochemistry staining methodOther
The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H\&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
light microscopyOther
The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H\&E staining and IHC).
medical chart reviewOther
Medical records are reviewed to obtain information from the pathology report on patient demographics, pathological characteristics of the surgical specimen, and clinical indication for the surgical procedure.
histopathologic examinationProcedure or surgery
The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H\&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
needle biopsyProcedure or surgery
Tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle.
spectroscopyProcedure or surgery
Optical spectra are acquired from ex vivo samples of normal and malignant breast tissue using diffuse reflectance, fluorescence, and Raman spectroscopy. Tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle. After the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of optical spectra from normal and malignant breast tissue samples
Measured: at time of excisional breast biopsy, lumpectomy, mastectomy or breast reduction surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Maryann Fitzmaurice, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918788
- Sponsor's protocol ID
- CASE9107
- Other IDs
- P30CA043703, CASE9107, CASE-9107-CC482
- Status last verified
- Aug 2013
- First submitted
- 10 Jun 2009
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Spectroscopy of Breast Tissue Through a Needle Device
- ClinicalTrials.gov ID
- NCT00918788
- Acronym / sponsor ID
- CASE9107
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Jun 2009 (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.
RATIONALE: Collecting and storing samples of breast tissue from patients who have undergone biopsy or surgery to test in the laboratory may help the study of cancer in the future.
PURPOSE: This laboratory study is looking at samples of breast tissue from women who have undergone breast biopsy or surgery.
Detailed description
OBJECTIVES:
- To prove that optical spectra collected by inserting an optical fiber probe into breast tissue through a biopsy needle can be of adequate quality to render a spectroscopic diagnosis.
OUTLINE: Optical spectra are acquired from ex vivo samples of normal and malignant breast tissue using diffuse reflectance, fluorescence, and Raman spectroscopy. Tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle. After the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements. The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H\&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
Medical records are reviewed to obtain information from the pathology report on patient demographics, pathological characteristics of the surgical specimen, and clinical indication for the surgical procedure.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary Care Clinic
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 |
|---|---|---|
| biologic sample preservation procedureEx vivo samples of normal and malignant breast tissue; biopsy specimens are then fixed in formalin and submitted for histopathologic studies | Other | – |
| immunohistochemistry staining methodThe biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H\&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results. | Other | – |
| light microscopyThe biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H\&E staining and IHC). | Other | – |
| medical chart reviewMedical records are reviewed to obtain information from the pathology report on patient demographics, pathological characteristics of the surgical specimen, and clinical indication for the surgical procedure. | Other | – |
| histopathologic examinationThe biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H\&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results. | Procedure or surgery | – |
| needle biopsyTissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle. | Procedure or surgery | – |
| spectroscopyOptical spectra are acquired from ex vivo samples of normal and malignant breast tissue using diffuse reflectance, fluorescence, and Raman spectroscopy. Tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle. After the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements. | Procedure or surgery | – |
Primary outcome
Collection of optical spectra from normal and malignant breast tissue samples
Time frame: at time of excisional breast biopsy, lumpectomy, mastectomy or breast reduction surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Maryann Fitzmaurice, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Collection of optical spectra from normal and malignant breast tissue samples (time frame: at time of excisional breast biopsy, lumpectomy, mastectomy or breast reduction surgery). 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 22 Aug 2013.