Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a live biobank study for breast cancer (BC) patients where samples will be collected at inflection points in the course of the disease.
To test this hypothesis the investigators will focus on studying BC 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. BC 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Patients with breast cancer (BC), any stage will be considered for this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Biobank | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| establish a live biobank for breast cancer patients | Tumor tissue will be obtained at key inflection points from breast cancer patients (BC): at initial diagnosis, at surgery and at metastasis or recurrence. Patient Derived Organoids (PDOs) will be prepared from tumors that are obtained from the BC patients. | 60 months |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
breast cancer patients (BC), any stage irrespective of hormonal status will be eligible for this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabiana Gregucci, M.D. | Contact | 646-962-3110 | fgr4002@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Formenti, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooklyn Methodist Hospital - NewYork Presbyterian | Recruiting | New York | New York | 11215 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Tissue collection through the DIGNITY trial will allow the investigators to study the individual tumor and its microenvironment from a biopsy specimen at sequential inflection points and to perform functional genomics experiments using the PDOs technology to determine if the cancer cells can be reprogrammed using radiotherapy and other interventions. Paired blood samples from the patients at each time point will be collected to study circulating cytokines/chemokines, tumor-specific T cells, and innate immune cell response to the PDO.
|
| New York Presbyterian Hospital - Queens | Recruiting | New York | New York | 11355 | United States |
|
| D017437 |
| Skin and Connective Tissue Diseases |