Caris Chromoseq data collection for AML, MDS, and MPN
Official 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
Run by Caris Science, Inc. · NCT07680868 · Data updated 2026-11-12
This study tests how well the Caris Chromoseq assay helps categorize risk in patients with AML, MDS, or MPN compared with standard tests.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Caris Science, Inc. Industry-sponsored |
| Locations | 1 site (Phoenix, Arizona) |
| Status | Recruiting |
| Started | July 2026 |
| Main results expected | July 2029 |
| Study ends | July 2029 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07680868 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with AML, MDS, or MPN for whom their physician orders Caris Chromoseq and standard cytogenetics, FISH, and NGS testing within a similar timeframe.
✕Probably not a fit
Patients whose Chromoseq results do not change clinical management may not see a direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects clinical data from patients who undergo the Caris Chromoseq assay for hematologic malignancies. It aims to compare Chromoseq’s risk stratification, ease of use, and turnaround time against conventional cytogenetics, FISH, and NGS. Participants must be adults with AML, MDS, or MPN and have Chromoseq ordered by their physician, alongside standard genomic testing. Data collection focuses on real-world use in a single sponsor site, Caris Life Sciences in Phoenix, AZ.
Why it matters
Potential benefit: If successful, Chromoseq could offer faster and more informative risk stratification for patients.
How similar studies have gone: Prior studies in genomic risk stratification have shown mixed but promising results for advanced sequencing approaches in hematologic malignancies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Caris Life Sciences
Phoenix, Arizona, United States Recruiting
Study contacts
- Study coordinator: Mary Baker
- Email: carisresearch@carisls.com
- Phone: 602-571-2771
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.