Recruiting

NCT Number: NCT07680868

Caris Chromoseq Data Collection

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.

Recruiting

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Key information

Conditions

Acute Myeloid Leukemia (AML) Bone Marrow Diseases Disease Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases Myelodysplatic Syndromes Myeloproliferative Disorders Myeloproliferative Neoplasm Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caris Life Sciences

Phoenix, Arizona, 85040, United States

Location status: Recruiting

Location contact

Mary Baker

CONTACT

[email protected]

602-571-2771

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Stated willingness to comply with all study procedures and availability for the duration of the study and has signed consent form
Subject must be 18 or older
Subject be diagnosed with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or myeloproliferative neoplasms (MPN)
Physician must order or plan to order Caris Chromoseq for their patient
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:

Patient for whom Caris Chromoseq is not being ordered
Patient is pregnant or lactating
Patient is not able or willing to provide consent to data collection for this protocol

Treatment and study plan

Caris Chromoseq

Diagnostic Test

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.

Primary outcomes

Caris Chromoseq vs Conventional Testing

Time frame: 2 years

To describe the concordance between the Caris Chromoseq assay and conventional cytogenetics performed in risk stratification of AML, MDS, and MPN

Study contacts

Contact information is provided by the study sponsor or research team.

Harshita Mittal

CONTACT

[email protected]

617-862-1263

Mary Baker

CONTACT

[email protected]

602-571-2771

Sponsors and collaborators

Lead sponsor

Caris Science, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jul 2, 2026
Registry last updated: Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting