Collection of breast cancer tissue and blood samples
Official title: Prospective Breast Cancer Biospecimen Collection
Run by Thomas Jefferson University · NCT04074720 · Data updated 2026-11-12
This study is collecting breast cancer tissue and blood samples from patients during surgery to help with future research on the disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | May 10, 2018 |
| Main results expected | July 1, 2028 |
| Study ends | July 1, 2028 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT04074720 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are undergoing surgical procedures for invasive breast cancer or carcinoma in situ.
✕Probably not a fit
Patients under 18 years old or those unable to provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study involves the collection of tissue samples during standard surgical procedures for patients diagnosed with breast cancer. In addition to tissue, a one-time blood draw will be performed, and there may be an optional rectal swab for biome analysis. The follow-up will consist of chart reviews to monitor for recurrence, metastases, or death. The goal is to gather biospecimens that can be used for future research on breast cancer.
Why it matters
Potential benefit: If successful, this study could enhance understanding of breast cancer biology and improve future treatment strategies.
How similar studies have gone: Other studies involving biospecimen collection in cancer research have shown success in advancing understanding and treatment options, making this approach well-established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Nicole Simone, MD — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Study coordinator: Nicole Simone, MD
- Email: Nicole.Simone@jefferson.edu
- Phone: 215-955-6702
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.