Recruiting

Caris Chromoseq

Sponsor:

Caris Science, Inc.

Code:

NCT07680868

Conditions

Acute Myeloid Leukemia (AML)

Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases

Myelodysplatic Syndromes

Myeloproliferative Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Caris Chromoseq

Study Details

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)

Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases

Myelodysplatic Syndromes

Myeloproliferative Neoplasm

Study ID

NCT07680868

Start date

Jul, 2026

Status verified date

Jun, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Caris Chromoseq

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 outcome measure

  • Caris Chromoseq vs Conventional Testing [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Caris Life Sciences

Recruiting

Phoenix, Arizona, United States, 85040

Contacts

More Information

Sponsor

Caris Science, Inc.

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Chromoseq
  • Caris
  • AML
  • MDS
  • MPN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Caris Science, Inc. on 2026-07-02.