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Prospective Breast Cancer Biospecimen Collection

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: NCT04074720
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death

Condition or disease Intervention/treatment Phase
Breast Cancer Invasive Breast Cancer Carcinoma in Situ of the Breast Procedure: Tissue Sample collection Other: Blood Sample Collection Other: Rectal Swab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prospective Breast Cancer Biospecimen Collection
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : January 22, 2021
Estimated Study Completion Date : January 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Standard of Care
patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab
Procedure: Tissue Sample collection
Tissue sample collected following standard of care procedure patient was already scheduled to have

Other: Blood Sample Collection
A one time sample of blood will be collected on day of standard of care procedure

Other: Rectal Swab
optional rectal swab may be collected on day of standard of care procedure




Primary Outcome Measures :
  1. Tumor biomarker identification [ Time Frame: Up to 5 years ]
    Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2).


Secondary Outcome Measures :
  1. Laboratory-based breast cancer tumor genomic profile [ Time Frame: Up to 5 years ]
    Genomic profile will be based on laboratory analysis of the collected tumor tissue biospecimens to identify how genes interact with the tumor and its environment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults >18 years old at time of consent
  • Subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf.
  • Patients with carcinoma in situ or invasive breast cancer
  • Patient must be undergoing one of the following:

    • definitive surgical tumor resection for breast cancer OR
    • placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer OR
    • neurosurgical resection of a brain metastasis from primary breast cancer.

Exclusion Criteria:

  • <18 years old
  • Not able to give informed consent and does not have acceptable surrogate capable to giving informed consent.
  • Active drug/alcohol dependence or abuse history

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): NCT04074720


Contacts
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Contact: Nicole Simone, MD 215-955-6702 Nicole.Simone@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Nicole Simone    215-955-6702    Nicole.Simone@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Nicole Simone, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04074720    
Other Study ID Numbers: 16D.674
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma in Situ
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type