Caris Chromoseq Data Collection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caris Chromoseq.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia (AML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Myelodysplatic Syndromes, Myeloproliferative Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Diagnostic test 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 measures
- Caris Chromoseq vs Conventional Testing [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Caris Life Sciences — Phoenix
Identifiers
NCT: NCT07680868 · CRO-006-0426