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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00117742 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Foundation Medicine | INDUSTRY |
| Avon Foundation | OTHER |
| Biocept, Inc. | INDUSTRY |
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The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions.
The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions. As tumor samples can be difficult to collect, we hope to be able to collect similar genetic information from blood or urine samples that we find in tumor tissue. Ultimately, we hope to identify genes important to cancer cells that could potentially identify standard-of-care or research-based recommendations for therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genetic profiling | Other | All participants will undergo genetic profiling. Archival tissue will be requested to undergo routine review for possible treatment recommendations. Blood samples will be obtained to study research correlates (plasma tumor DNA, ptDNA) and tissue comparison. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment recommendation | Other | Depending on the results from the participant's archival tissue, a panel of Johns Hopkins investigators will meet to interpret the molecular and genetic profiling results in order to identify any actionable mutations to provide a personalized treatment recommendation for the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability of genetically profiling of ptDNA as assessed by identifying the proportion of genetic alterations in tumor tissue | The proportion of genetic alterations in tumor tissue is detected via genetic profiling of ptDNA when those genetic alterations are present in the tumor at an allelic frequency >10%. | 1 year |
| Percentage of patients who cannot have NGS of metastatic site biopsy but have clinically actionable mutations detected via genetic profiling of ptDNA | Percentage of patients for which genetic profiling of ptDNA would be more feasible when a metastatic biopsy cannot be acquired. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Response as assessed by change in ptDNA level up to 2 weeks post-intervention. To determine whether a 10-fold decrease in allelic frequency of a given mutation in ptDNA after initiating new systemic therapy can predict for response to treatment. | Change in number-of-folds decrease in allelic frequency of a given mutation in ptDNA 1 or 2 weeks after beginning new systemic therapy. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vered Stearns, M.D. | Johns Hopkins University | Principal Investigator |
| Jenna Canzoniero, MD | SKCCC Johns Hopkins Medical Institution | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287-0013 | United States | ||
Individual participant data will not be shared.
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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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| Response as assessed by Change in Circulating tumor cell (CTC) counts | Measure CTC counts at baseline, after 1-2 weeks of therapy, and at each restaging, up to 1 year. | Change from baseline up to 1 year |
| Allegheny Health Network Cancer Institute |
| Pittsburgh |
| Pennsylvania |
| 15212 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |