NCT07680868Recruiting
Caris Chromoseq Data Collection
Caris Science, Inc.
Start Date
7/1/2026
Completion Date
7/1/2029
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 Criteria
Age Range: 18 years to No maximum
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
Interventions
DIAGNOSTIC_TEST
Caris Chromoseq
Conditions
Acute Myeloid Leukemia (AML)Myelodysplastic (MDS) / Myeloproliferative (MPN) DiseasesMyelodysplatic SyndromesMyeloproliferative Neoplasm
Locations
Caris Life Sciences
Phoenix, Arizona 85040
United States