Acute Myeloid Leukemia (AML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Myelodysplatic Syndromes, Myeloproliferative Neoplasm
Conditions
Keywords
Chromoseq, Caris, AML, MDS, MPN
Brief 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.
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.
Sponsors
Caris Science, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, MDS, or MPN within the same timeframe of Caris Chromoseq without intervening line of therapy.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Patient for whom Caris Chromoseq is not being ordered 2. Patient is pregnant or lactating 3. Patient is not able or willing to provide consent to data collection for this protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caris Chromoseq vs Conventional Testing | 2 years | To describe the concordance between the Caris Chromoseq assay and conventional cytogenetics performed in risk stratification of AML, MDS, and MPN |
Countries
United States
Contacts
CONTACTMary Baker
CONTACTHarshita Mittal
Outcome results
None listed