Prospective Breast Cancer Biospecimen Collection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThomas Jefferson University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
definitive surgical tumor resection for breast cancer OR
Disqualifiers
<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 population
Adults (≥18 years old) with newly diagnosed in situ carcinoma or invasive breast cancer, or patients with primary breast cancer with metastasis to the brain. Up to 200 newly diagnosed breast cancer patients, and 36 patients with brain metastases.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tissue Sample collection
Procedure/SurgeryTissue sample collected following standard of care procedure patient was already scheduled to have
Blood Sample Collection
Other interventionA one time sample of blood will be collected on day of standard of care procedure
Rectal Swab
Other interventionoptional rectal swab may be collected on day of standard of care procedure
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Group 1: Newly Diagnosed Breast Cancer Patients3 interventions
Group B: Group 2: Patients with Brain Metastases from Primary Breast Cancer3 interventions
Trial outcomes
Primary outcomes
1
Tumor biomarker identification
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).
Time frame
Up to 5 yearsSecondary outcomes
1
Laboratory-based breast cancer tumor genomic profile
Genomic profile will be based on laboratory analysis of the collected tumor tissue biospecimens to identify how genes interact with the tumor and its environment.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov