Breast CancerNCT00897338
Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer
An observational study of Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Studying samples of blood and pleural or peritoneal fluid from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how breast cancer begins and spreads in the body. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- flow cytometry, fluorescence activated cell sorting and immunohistochemistry staining method
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2014
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic breast cancer patients
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Metastatic disease (stage IV)
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-1000
About this study
Official title: A Feasibility Study of a Novel Technique to Identify Circulating Breast Cancer Cells in Patients With Metastatic Breast Cancer
RATIONALE: Studying samples of blood and pleural or peritoneal fluid from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how breast cancer begins and spreads in the body.
PURPOSE: This research study is looking at a new way of identifying circulating breast cancer cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To compare identification of circulating breast cancer cells (CBCCs) in blood or pleural or peritoneal fluid by a novel technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) to the standard technique using the CellSearch® system in women with metastatic breast cancer.
Secondary
- To determine whether CBCCs have the potential to grow into metastatic lesions.
OUTLINE: Patients undergo sample collection to help develop a new technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) in isolating circulating breast cancer cells (CBCCs) from blood and pleural or peritoneal fluid. Blood may also be drawn to measure the number of circulating tumor cells using the standard CellSearch® system.
Mononuclear cells are isolated by density centrifugation. Cells are stained against surface antigens that provide specific expression patterns for CBCCs (CD44, CD24). Cells are analyzed on a fluorescence activated cell sorting (FACS) Calibur flow cytometer and sequentially gated (ALDHhigh→CD44+ vs CD24-/low or CD44+ vs CD24-/low→ALDHhigh) for detection of CBCCs. For further confirmation of epithelial origin, ALDHhighCD44+CD24-/low cells are isolated using a FACSAria flow sorter, cytocentrifuged onto glass slides then stained for the expression of epithelial-specific cytokeratins 5, 8, 14, 18 and 19 by standard immunohistochemical techniques. Using the phenotype that is found to most highly enrich for epithelial cells, cells are isolated by FACS and assayed for clonogenic growth.
- Conditions
- Breast Cancer
- Being tested
- flow cytometry, fluorescence activated cell sorting, immunohistochemistry staining method, immunologic technique, biomarker analysis
- Keywords
- stage IV 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.
flow cytometryOther
laboratory analysis
fluorescence activated cell sortingOther
laboratory analysis
immunohistochemistry staining methodOther
laboratory analysis
immunologic techniqueOther
laboratory analysis
biomarker analysisOther
laboratory analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of novel technique to identify and isolate circulating breast cancer cells
Measured: Baseline
Comparison of this novel technique with the CellSearch™ system
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startAug 2007
- Primary completionJan 2014
- Study completionJan 2014
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vered Stearns, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897338
- Sponsor's protocol ID
- J0737 CDR0000571962
- Other IDs
- P30CA006973, JHOC-J0737
- Status last verified
- Oct 2015
- First submitted
- 9 May 2009
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Novel Technique to Identify Circulating Breast Cancer Cells in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00897338
- Acronym / sponsor ID
- J0737 CDR0000571962
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2007
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 May 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: Studying samples of blood and pleural or peritoneal fluid from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how breast cancer begins and spreads in the body.
PURPOSE: This research study is looking at a new way of identifying circulating breast cancer cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- To compare identification of circulating breast cancer cells (CBCCs) in blood or pleural or peritoneal fluid by a novel technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) to the standard technique using the CellSearch® system in women with metastatic breast cancer.
Secondary
- To determine whether CBCCs have the potential to grow into metastatic lesions.
OUTLINE: Patients undergo sample collection to help develop a new technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) in isolating circulating breast cancer cells (CBCCs) from blood and pleural or peritoneal fluid. Blood may also be drawn to measure the number of circulating tumor cells using the standard CellSearch® system.
Mononuclear cells are isolated by density centrifugation. Cells are stained against surface antigens that provide specific expression patterns for CBCCs (CD44, CD24). Cells are analyzed on a fluorescence activated cell sorting (FACS) Calibur flow cytometer and sequentially gated (ALDHhigh→CD44+ vs CD24-/low or CD44+ vs CD24-/low→ALDHhigh) for detection of CBCCs. For further confirmation of epithelial origin, ALDHhighCD44+CD24-/low cells are isolated using a FACSAria flow sorter, cytocentrifuged onto glass slides then stained for the expression of epithelial-specific cytokeratins 5, 8, 14, 18 and 19 by standard immunohistochemical techniques. Using the phenotype that is found to most highly enrich for epithelial cells, cells are isolated by FACS and assayed for clonogenic growth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic breast cancer patients
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 |
|---|---|---|
| flow cytometrylaboratory analysis | Other | – |
| fluorescence activated cell sortinglaboratory analysis | Other | – |
| immunohistochemistry staining methodlaboratory analysis | Other | – |
| immunologic techniquelaboratory analysis | Other | – |
| biomarker analysislaboratory analysis | Other | – |
Primary outcome
Feasibility of novel technique to identify and isolate circulating breast cancer cells
Time frame: Baseline
Comparison of this novel technique with the CellSearch™ system
Time frame: Baseline
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 12 Oct 2015.
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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.
Vered Stearns, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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?
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: finished, as of the sponsor's last update on 12 Oct 2015. 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?
Feasibility of novel technique to identify and isolate circulating breast cancer cells (time frame: Baseline). 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 12 Oct 2015.