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Prospective Breast Cancer Biospecimen Collection

Primary Purpose

Breast Cancer, Invasive Breast Cancer, Carcinoma in Situ of the Breast

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tissue Sample collection
Blood Sample Collection
Rectal Swab
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standard of Care

Arm Description

patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab

Outcomes

Primary Outcome Measures

Tumor biomarker identification
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

Laboratory-based breast cancer tumor genomic profile
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.

Full Information

First Posted
August 1, 2019
Last Updated
August 14, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04074720
Brief Title
Prospective Breast Cancer Biospecimen Collection
Official Title
Prospective Breast Cancer Biospecimen Collection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
August 11, 2028 (Anticipated)
Study Completion Date
August 11, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Invasive Breast Cancer, Carcinoma in Situ of the Breast

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Other
Arm Description
patients will have tissue procured after a standard of care procedure, a one time blood draw performed, and optional rectal swab
Intervention Type
Procedure
Intervention Name(s)
Tissue Sample collection
Intervention Description
Tissue sample collected following standard of care procedure patient was already scheduled to have
Intervention Type
Other
Intervention Name(s)
Blood Sample Collection
Intervention Description
A one time sample of blood will be collected on day of standard of care procedure
Intervention Type
Other
Intervention Name(s)
Rectal Swab
Intervention Description
optional rectal swab may be collected on day of standard of care procedure
Primary Outcome Measure Information:
Title
Tumor biomarker identification
Description
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).
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Laboratory-based breast cancer tumor genomic profile
Description
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.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Simone, MD
Phone
215-955-6702
Email
Nicole.Simone@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Simone, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Simone
Phone
215-955-6702
Email
Nicole.Simone@jefferson.edu

12. IPD Sharing Statement

Learn more about this trial

Prospective Breast Cancer Biospecimen Collection

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