T-Cell Lymphoproliferative Disorder
Conditions
Brief summary
This protocol describes the pivotal accuracy study for the IdentiClone Dx TRG Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC TRG Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from FFPE (Formalin Fixed Paraffin Embedded) samples from individuals with suspected T-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx TRG (FR1/FR2/FR3) Assays - MiSeq (LT Dx TRG-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC TRG Assay on the same sample type.
Interventions
DIAGNOSTIC_TESTIdentiClone Dx TRG Assay
The IdentiClone Dx TRG Assay (Assay) is an in vitro diagnostic product intended for qualitative capillary electrophoresis based-detection of clonality in T-cell receptor gamma chain (TRG) gene rearrangements in Formalin-Fixed Paraffin-Embedded (FFPE) specimens as an adjunctive method for the diagnosis of T-cell lymphoproliferative disease. This qualitative, non-automated Assay is for use on the ABI 3500xL Dx and ABI 3500xL Genetic Analyzers.
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. De-identified, residual FFPE specimens with a minimum of 8 curls 2. Subject Age ≥ 18 3. For suspected clonal positive specimens, FFPE specimens of subjects diagnosed (at the time the specimen was drawn) with T-cell Lymphoproliferative disease with at least one of the following: 1. ICD10 Codes: C84, C85.8, C85.9, C86.1, C86.2, C86.3, C86.5, 86.6, C91.5, C91.6, C91.0, C91.z, C91.9, C94, C95, C96, or other T-cell lymphoma diagnosis 2. b. T-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., SNOMED) 3. Mycosis fungoides or Sézary syndrome sample are acceptable 4. For suspected clonal negative specimens, FFPE specimens of subjects suspected of T-cell lymphoproliferative disease but diagnosed negative for T-cell lymphoproliferative disease. Up to 20% of the negative specimens may be from normal tissue or tissue diagnosed with diseases other than T-cell lymphoproliferative disease
Exclusion criteria
1.FFPE specimens that were fixed using formalin substitute (ethanol, methanol, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Agreement | Through Study Completion at one year | Agreement between the results of the Invivoscribe IdentiClone Dx TRG Assay and the LymphoTrack Dx TRG (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