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The study will collect clinical data on patients who receive the Caris Chromoseq assay for an underlying hematologic malignancy. The assay provides risk stratification for patients with acute myeloid leukemia (AML) myelodysplastic syndrome (MDS), or myeloproliferative neoplasms (MPN). The hypothesis of the study is that Caris Chromoseq compares favorably to conventional cytogenetics, FISH, and NGS analysis in terms of risk stratification capabilities, ease of use, and turnaround time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AML, MDS and/or MPN | The study will include approximately 300 subjects in the United States with either AML, MDS and/or MPN who receive the Caris Chromoseq assay who also undergo standard institutional directed conventional cytogenetic analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caris Chromoseq | Diagnostic Test | The Caris Chromoseq assay is designed to provide whole genome profiling of hematologic malignancies in the human genome. Various internal studies have been performed that validate the performance of these genetic alterations including SNVs, CNAs, INDELs, and SVs in AML, MDS, and MPN. |
| Measure | Description | Time Frame |
|---|---|---|
| Caris Chromoseq vs Conventional Testing | To describe the concordance between the Caris Chromoseq assay and conventional cytogenetics performed in risk stratification of AML, MDS, and MPN | 2 years |
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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The study will include approximately 300 subjects in the United States with either AML, MDS and/or MPN who receive the Caris Chromoseq assay who also undergo standard institutional directed conventional cytogenetic analysis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Baker | Contact | 602-571-2771 | carisresearch@carisls.com | |
| Harshita Mittal | Contact | 617-862-1263 | hmittal@carisls.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caris Life Sciences | Recruiting | Phoenix | Arizona | 85040 | United States |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D004194 | Disease |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001855 | Bone Marrow Diseases |