Prospective Breast Cancer Biospecimen Collection

Thomas Jefferson University

Status: Enrolling

Conditions: Breast Cancer; Carcinoma in Situ of the Breast; Invasive Breast Cancer

Treatments: Procedure: Tissue Sample collection; Other: Blood Sample Collection; Other: Rectal Swab

Study type: Interventional

Funder types: Other

Identifiers

NCT04074720

16D.674

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Standard of Care

Other group

Description:

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

Treatment:

Other: Rectal Swab

Other: Blood Sample Collection

Procedure: Tissue Sample collection