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| ID | Type | Description | Link |
|---|---|---|---|
| JT 8877 | Other Identifier | JeffTrial Number |
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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
This is a breast cancer biospecimen and possible metastasis procurement study with the goal of obtaining specimens appropriately for genomic and proteomic analysis. Other than reviewing and signing the consent form by the participants in the study, and the study-specific blood tissue procurement and blood draw (and optional biome specimen), all care and clinical encounters will be as per standard of care. There are four times when tissue may be procured and an optional biome specimen collection depending on the treatment course the treating team decides upon. The technique will be chosen based on physician discretion, patient medical treatment, and patient preference. Treatment regimen will consist of tumor sampling/extraction, one blood draw, optional biome specimen collection, and sample storing. This is a single arm study; all participants will have tissue and blood sample procured for biospecimen analysis and repository. Patients have the option to donate a biome specimen as well. Providing the biome sample is optional and will not influence eligibility to patient participation in this study. There will be no assignment or randomization to different treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Newly Diagnosed Breast Cancer Patients | 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. |
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| Group 2: Patients with Brain Metastases from Primary Breast Cancer | The 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue Sample collection | Procedure | Tissue sample collected following standard of care procedure patient was already scheduled to have |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years |
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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:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Simone, MD | Contact | 215-955-6702 | Nicole.Simone@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Simone, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Tumor and normal adjacent tissue samples will be collected from approximately 200 living patients with breast cancer irrespective of hormone status under the care of TJUH clinicians. Serum will be collected at the same time as serum and adjacent normal so that serum exosomes as well as extracellular matrix influences can be examined.
| Blood Sample Collection | Other | A one time sample of blood will be collected on day of standard of care procedure |
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| Rectal Swab | Other | optional rectal swab may be collected on day of standard of care procedure |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |