Caris Chromoseq Data Collection

Caris Science, Inc.300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Acute Myeloid Leukemia (AML)Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases Myelodysplatic Syndromes Myeloproliferative Neoplasm

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 2 years

Data from ClinicalTrials.gov

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