NCT07680868RecruitingNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Caris Science, Inc.
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Caris Chromoseq vs Conventional Testing
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Caris Chromoseq vs Conventional Testing
Time Frame: 2 years
To describe the concordance between the Caris Chromoseq assay and conventional cytogenetics performed in risk stratification of AML, MDS, and MPN
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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