Caris Chromoseq Data Collection

NCT07680868 | Recruiting

• 1 other identifier: CRO-006-0426
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chromoseq; Caris; AML; MDS; MPN

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

AML, MDS and/or MPN

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.

Diagnostic Test: Caris Chromoseq

Interventions

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.

AML, MDS and/or MPN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Caris Science, Inc.: lead

Study Sites (1)

Caris Life Sciences

Phoenix, Arizona, 85040, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Disease; Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Marrow Diseases

Central Study Contacts

Mary Baker

CONTACT

602-571-2771; carisresearch@carisls.com

Harshita Mittal

CONTACT

617-862-1263; hmittal@carisls.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)