NCT04074720 · Thomas Jefferson University
Prospective Breast Cancer Biospecimen Collection
What this study is about
Tissue will be procured during a the usual treatment 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.
View original scientific description
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.
Interventions
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
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 3, 2025 · Source of record for eligibility and locations