An Observational Study to Describe the Performance of Caris Chromoseq as Compared to Conventional Cytogenetics, FISH, and NGS Testing Among Patients Receiving the Caris Chromoseq Assay for Hematologic Malignancies
Caris Science, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study and has signed consent form 2. Subject must be 18 or older 3. Subject be diagnosed with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or myeloproliferative neoplasms (MPN) 4. Physician must order or plan to order Caris Chromoseq for their patient 5. Physicians must order or have ordered conventional cytogenetics, FISH, and NGS testing for AML, MD…
Interventions
- Diagnostic TestCaris Chromoseq
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.
Location
- Caris Life SciencesPhoenix, Arizona