De-convoluting Interactions Between Genes, the Cancer Environment, and the Immune System to Develop Therapies That Work for You

Study Overview
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Brief Summary
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This is a live biobank study for Triple negative breast cancer (TNBC) patients where samples will be collected at inflection points in the course of the disease.

Detailed Description
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To test this hypothesis the investigators will focus on studying TNBC patients using an innovative approach, the DIGNITY Study (De-convoluting interactions between genes, the cancer environment, and the immune system to develop therapies that work for you) designed to building a live tissue biobank of Patient Derived Tumor Organoids (PDOs) derived from tumor at surgery, preceded or not by neoadjuvant therapy (NAT), and at recurrence/metastasis. TNBC patients enrolled in this study are consented to enable investigators to generate a biobank of tumor tissue (obtained from surgically removed excess that would otherwise be disposed off ) and matched blood cells ( obtained from an already existing line or a venipuncture ordered per standard of care testing) at key timepoints in their treatment course.

Official Title
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De-convoluting Interactions Between Genes, the Cancer Environment, and the Immune System to Develop Therapies That Work for You

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Procedure: Live Biobank


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients will historically proven TNBC are eligible to be on the study Exclusion Criteria: Carriers of other breast cancers than TNBC.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients with triple negative breast cancer (TNBC), any stage will be considered for this study. | Procedure: Live Biobank<br>* Tumor tissue will be collected from consented patients at sequential inflection points in the disease course: at the time of initial diagnosis, at the time of surgery and during recurrence or metastasis. In addition to this, 40ml of research bloods will also be collected at these key inflection points.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| establish a live biobank for triple negative breast cancer patients | Tumor tissue will be obtained at key inflection points from Triple negative breast cancer patients (TNBC): at initial diagnosis, at surgery and at metastasis or recurrence. Patient Derived Organoids (PDOs) will be prepared from tumors that are obtained from the TNBC patients. | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess immune relevant genes from tumor biopsies | comprehensively characterize the tumor from the biospecimen to determine the mutations, expression of immune related genes, and the quality and the spatial distribution of the immune infiltrate | 60 months |