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

Part of paid clinical trials in San Diego, California.

Sponsor
Invivoscribe, Inc.
Study ID
NCT06876571
Status
Not Yet Recruiting

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Conditions

  • T-Cell Lymphoproliferative Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 2, 2025
Status verified
Mar 2025
Primary completion
Nov 6, 2025
Completion
Dec 6, 2025

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: T-Cell Positive Lymphoproliferative Disorders
    FFPE Samples for subjects with T-Cell Positive Lymphoproliferative Disorders
  • Arm: FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders
    FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders

Primary Outcome Measure

% Agreement [ Time Frame: Through Study Completion at one year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Invivoscribe, Inc.San DiegoCalifornia92103-

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Invivoscribe, Inc.· San Diego, CA