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
Sponsor study identifier
observational
300
1 country
1
Study Start
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 26, 2026
Actual (reported)July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2, 2026
Actual (reported)July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
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.
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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.
Caris Life Sciences
Phoenix, Arizona, 85040, United States
First Submitted
June 26, 2026
First Posted
July 2, 2026
Study Start
July 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2029
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 2, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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