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NCT Number: NCT06876571

Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay

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.

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Key information

Conditions

T-Cell Lymphoproliferative Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LabPMM GmbH, Hallbergmoos, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

IdentiClone Dx TRG Assay

Diagnostic Test

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.

Other names: IdentiClone Dx IGH (IC IGH Dx) Assay

Primary outcomes

% Agreement

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Invivoscribe, Inc.

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 14, 2025
Registry last updated: Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.