Recruiting

Observational Study

Sponsor:

Thomas Jefferson University

Code:

NCT04074720

Conditions

Breast Cancer

Invasive Breast Cancer

Carcinoma in Situ of the Breast

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tissue Sample collection

Blood Sample Collection

Rectal Swab

Study Details

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

Conditions

Breast Cancer

Invasive Breast Cancer

Carcinoma in Situ of the Breast

Study ID

NCT04074720

Start date

May 10, 2018

Status verified date

Nov, 2025

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1: Newly Diagnosed Breast Cancer Patients

Tissue will be procured during a standard of care procedure the patient will already have scheduled. 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.

Group 2: Patients with Brain Metastases from Primary Breast Cancer

The brain metastasis specimen experiments will use tissue from 36 patients (12 per subtype: estrogen positive, Her-neu-2 positive, and triple negative). Tissue will be procured during a standard of care procedure the patient will already have scheduled. 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.

Interventions

Tissue Sample collection

Tissue sample collected following standard of care procedure patient was already scheduled to have

Blood Sample Collection

A one time sample of blood will be collected on day of standard of care procedure

Rectal Swab

optional rectal swab may be collected on day of standard of care procedure

Primary outcome measure

  • Tumor biomarker identification [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Nicole Simone, MD

215-955-6702Nicole.Simone@jefferson.edu

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Nicole Simone

2159556702Nicole.Simone@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Keywords

  • Breast Cancer
  • Tumor Tissue Collection
  • Serum Collection
  • Plasma Collection
  • Fresh Tissue Collection
  • Fixed Tissue Collection
  • Translational Research
  • Biospecimen Collection
  • Surgical Resection
  • Vascular Access Placement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-12-03.