Prospective Breast Cancer Biospecimen Collection
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Thomas Jefferson University
- Study ID
- NCT04074720
- Status
- Recruiting
Conditions
- Breast Cancer
- Carcinoma in Situ of the Breast
- Invasive Breast Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tissue Sample collection — PROCEDURETissue sample collected following standard of care procedure patient was already scheduled to have
- Blood Sample Collection — OTHERA one time sample of blood will be collected on day of standard of care procedure
- Rectal Swab — OTHERoptional rectal swab may be collected on day of standard of care procedure
Study Details
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
Key Dates
- Start date
- May 10, 2018
- Status verified
- Nov 2025
- Primary completion
- Jul 1, 2028
- Completion
- Jul 1, 2028
Study Design
- Enrollment
- 200 participants (estimated)
Arms
- Arm: Group 1: Newly Diagnosed Breast Cancer PatientsTissue 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.
- Arm: Group 2: Patients with Brain Metastases from Primary Breast CancerThe 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.
Primary Outcome Measure
Tumor biomarker identification [ Time Frame: Up to 5 years ]
Central Contacts
- Nicole Simone, MD215-955-6702
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 |
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