Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay
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: IdentiClone Dx TRG Assay.
- Who it may be relevant to
- Registry conditions: T-Cell Lymphoproliferative Disorder. 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, Germany, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test IdentiClone 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.
Primary outcome measures
- % Agreement [Time frame: Through Study Completion at one year]
Eligibility criteria
Inclusion criteria
- De-identified, residual FFPE specimens with a minimum of 8 curls
- Subject Age ≥ 18
- 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:
- 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
- b. T-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., SNOMED)
- Mycosis fungoides or Sézary syndrome sample are acceptable
- 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.)
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
- Other
Study locations
United States · 1 center
- Invivoscribe, Inc. — San Diego
Germany · 1 center
- LabPMM GmbH — Hallbergmoos
Japan · 1 center
- LabPMM GK — Kawasaki-shi
Identifiers
NCT: NCT06876571 · IVS-109-001