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Molecular and Cellular Analysis of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02243397
Recruitment Status : Recruiting
First Posted : September 17, 2014
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief 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. The different types of cells in breast cancer impacts the way individuals respond to various treatments.

Condition or disease
Breast - Female Breast - Male

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular and Cellular Analysis of Breast Cancer
Study Start Date : September 2014
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
blood, cerebrospinal fluid, abdominal fluid, chest fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
breast cancer patients at Stanford Cancer Center
Criteria

Inclusion Criteria:

  1. Histologically proven diagnosis of breast cancer or a carcinoma of unknown primary consistent with the presentation of a primary breast malignancy.
  2. 18 years of age or older.
  3. Ability to understand and the willingness to sign a written informed consent do

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243397


Contacts
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Contact: Michelle Aboytes 650-498-9071 mkay2@stanford.edu

Locations
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United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Michelle Aboytes    650-498-9071    mkay2@stanford.edu   
Principal Investigator: Kathleen Horst         
Principal Investigator: Maximilian Diehn         
Sub-Investigator: Edward Graves         
Sub-Investigator: Robert West         
Sub-Investigator: Frederick Dirbas         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kathleen Horst Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02243397    
Other Study ID Numbers: BRS0040
29691
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: April 2020