B-Cell Lymphoproliferative Disorder
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTIdentiClone Dx IGH (IC IGH Dx) Assay
The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease
Sponsors
Invivoscribe, Inc.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl 2. DNA extracted from PB specimens no more than 7 days 3. DNA stored at -15°C to -30°C up to 5 years 4. Donor Age: ≥ 18 5. For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with: 1. ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis 2. B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED) 6. For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease
Exclusion criteria
1\. PB specimens that have been frozen prior to extraction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Agreement | Through Study Completion at one year | Agreement between the results of the Invivoscribe IdentiClone Dx IGH Assay and the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq by assessing the positive and negative percent agreement between the two assays. |
Countries
Germany, Japan, United States
Outcome results
None listed