Clinical Trial

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

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Record status
This record was last updated March 14, 2025 (before its estimated November 6, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06876571
Lead Sponsor Invivoscribe, Inc.
Conditions T-Cell Lymphoproliferative Disorder
Enrollment 250 participants
Start Date 2025-06-02
Primary Completion 2025-11-06 (estimated)
Study Completion 2025-12-06 (estimated)
Updated on ClinicalTrials.gov 2025-03-14