Breast - FemaleNCT02243397
Molecular and Cellular Analysis of Breast Cancer
An observational study of Breast - Female and Breast - Male, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to investigate the different types and subtypes of cells found in breast tumors. The investigators will do this using a variety of molecular analysis tools that may allow for improved tests. Read more about this study
- Who is it for?
- Ages 18 minutes and older, women only
- Conditions the study is for
- Breast - Female, Breast - Male
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2014to 19 Apr 2021
- 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 minutes and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: breast cancer patients at Stanford Cancer Center
Who may be able to join
- Histologically proven diagnosis of breast cancer or a carcinoma of unknown primary consistent with the presentation of a primary breast malignancy.
- 18 years of age or older.
- Ability to understand and the willingness to sign a written informed consent do
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Cancer Institute
Stanford, California, 94305
About this study
The purpose of the study is to investigate the different types and subtypes of cells found in breast tumors. The investigators will do this using a variety of molecular analysis tools that may allow for improved tests. The different types of cells in breast cancer impacts the way individuals respond to various treatments.
- Conditions
- Breast - Female, Breast - Male
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of GM-CSF in plasma
We will be measuring levels of GM-CSF (Granulocyte-macrophayge colony stimulating factor) from the plasma of the patient before during and after the irradiation treatment to study if there is any increase in the GM-CSF production
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study start10 Sep 2014
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast - FemaleStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Horst, Stanford University
- Investigators
- Kathleen Horst, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243397
- Sponsor's protocol ID
- IRB-29691
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2014
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Cellular Analysis of Breast Cancer
- ClinicalTrials.gov ID
- NCT02243397
- Acronym / sponsor ID
- IRB-29691
- Conditions
- Breast - Female, Breast - Male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 10 Sep 2014 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 17 Sep 2014 (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.
The purpose of the study is to investigate the different types and subtypes of cells found in breast tumors. The investigators will do this using a variety of molecular analysis tools that may allow for improved tests. The different types of cells in breast cancer impacts the way individuals respond to various treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 minutes and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- breast cancer patients at Stanford Cancer Center
Key inclusion criteria (3 listed)
- Histologically proven diagnosis of breast cancer or a carcinoma of unknown primary consistent with the presentation of a primary breast malignancy.
- 18 years of age or older.
- Ability to understand and the willingness to sign a written informed consent do
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
levels of GM-CSF in plasma
Time frame: 10 years
We will be measuring levels of GM-CSF (Granulocyte-macrophayge colony stimulating factor) from the plasma of the patient before during and after the irradiation treatment to study if there is any increase in the GM-CSF production
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 26 Nov 2025.
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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.
Kathleen Horst principal investigator
Stanford University
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 - Female and Breast - Male, run by Stanford University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 26 Nov 2025. 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?
levels of GM-CSF in plasma (time frame: 10 years). 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 26 Nov 2025.