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difficulty recruiting participants
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The purpose of this study is to create models out of tissue samples and treat those models with the same immunotherapy treatment the patient will be receiving, in order to validate this process and to predict responses to therapies and use it to choose the best treatments for people in the future. The researchers will then examine the direct effects of the treatment on those models.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Drug | Organoid samples will be collected at time of biopsy and cultured in the lab. The samples will then receive the same standard of care immunotherapy treatment as the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Calculate overall patient response rate | Compare patient response using RECIST 1.1 criteria and immune-organoid response based on the following criteria:
| Baseline to 12 months |
| Reliability of organoid development | calculate the percentage of biopsies with successful organoid development | Baseline to 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who are planning on receiving a fresh biopsy sample will be identified in the IU Oncology outpatient clinics or by referral from outside physicians.
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| Name | Affiliation | Role |
|---|---|---|
| Mateusz Opyrchal, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| D017437 |
| Skin and Connective Tissue Diseases |