Collection of breast cancer tissue and blood samples
Prospective Breast Cancer Biospecimen Collection
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04074720 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing surgical procedures for invasive breast cancer or carcinoma in situ.
Not a fit: Patients under 18 years old or those unable to provide informed consent will not benefit from this study.
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 performed: Other studies involving biospecimen collection in cancer research have shown success in advancing understanding and treatment options, making this approach well-established.
Eligibility criteria
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 this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.