Caris Chromoseq Data Collection

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Caris Science, Inc.
Study ID
NCT07680868
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Caris Life SciencesPhoenixArizona85040
Mary Baker
602-571-2771

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