Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
Completed
Conditions studied: B-Cell Lymphoproliferative Disorder
In brief
This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.
Key facts
- Study ID
- NCT06112301
- Run by
- Invivoscribe, Inc.
- People needed
- 250
- Starts
- 2024-01-02
- Expected to finish
- 2024-11-06
- Last updated by the study team
- 2024-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl
- DNA extracted from PB specimens no more than 7 days
- DNA stored at -15°C to -30°C up to 5 years
- Donor Age: ≥ 18
- For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:
- ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis
- B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)
- For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease
You may not qualify if…
- PB specimens that have been frozen prior to extraction
Where it is running
- Invivoscribe, Inc. — San Diego, California, United States
- LabPMM GmbH — Hallbergmoos, Germany
- LabPMM GK — Kawasaki-shi, Kanagawa, Japan
Full record on ClinicalTrials.gov
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