Prospective Breast Cancer Biospecimen Collection

Last updated: November 25, 2025
Sponsor: Thomas Jefferson University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Genitourinary Cancer

Ductal Carcinoma In Situ (Dcis)

Treatment

Blood Sample Collection

Rectal Swab

Tissue Sample collection

Clinical Study ID

NCT04074720
16D.674
JT 8877
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults >18 years old at time of consent

  • Subject must be capable to giving informed consent or have an acceptable surrogatecapable 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 forbreast cancer OR

  • neurosurgical resection of a brain metastasis from primary breast cancer.

Exclusion

Exclusion Criteria:

  • <18 years old

  • Not able to give informed consent and does not have acceptable surrogate capable togiving informed consent.

  • Active drug/alcohol dependence or abuse history

Study Design

Total Participants: 200
Treatment Group(s): 3
Primary Treatment: Blood Sample Collection
Phase:
Study Start date:
May 10, 2018
Estimated Completion Date:
July 01, 2028

Study Description

This is a breast cancer biospecimen and possible metastasis procurement study with the goal of obtaining specimens appropriately for genomic and proteomic analysis. Other than reviewing and signing the consent form by the participants in the study, and the study-specific blood tissue procurement and blood draw (and optional biome specimen), all care and clinical encounters will be as per standard of care. There are four times when tissue may be procured and an optional biome specimen collection depending on the treatment course the treating team decides upon. The technique will be chosen based on physician discretion, patient medical treatment, and patient preference. Treatment regimen will consist of tumor sampling/extraction, one blood draw, optional biome specimen collection, and sample storing. This is a single arm study; all participants will have tissue and blood sample procured for biospecimen analysis and repository. Patients have the option to donate a biome specimen as well. Providing the biome sample is optional and will not influence eligibility to patient participation in this study. There will be no assignment or randomization to different treatment groups.

Connect with a study center

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

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