Prospective Breast Cancer Biospecimen Collection

August 14, 2023 updated by: Thomas Jefferson University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Sidney Kimmel Cancer Center at Thomas Jefferson University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Nicole Simone, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2018

Primary Completion (Estimated)

August 11, 2028

Study Completion (Estimated)

August 11, 2028

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16D.674

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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