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.

Study Overview

• Status: Not yet recruiting
• Conditions: T-Cell Lymphoproliferative Disorder
• Intervention / Treatment: Diagnostic test: IdentiClone Dx TRG Assay

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Germany
  • Hallbergmoos, Germany, 85399
    • LabPMM GmbH
• Japan
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 210-0821
      • LabPMM GK
      • Contact: Masato Sasaki; Phone Number: +81 80 9076 7063; Email: msasaki@labpmm.co.jp
• United States
  • California
    • San Diego, California, United States, 92103
      • Invivoscribe, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Samples from subjects with diagnosed T-Cell Lymphoproliferative disorders or suspected of T-Cell Lymphoproliferative disorders with negative T-Cell Clonality Testing results

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T-Cell Positive Lymphoproliferative Disorders; FFPE Samples for subjects with T-Cell Positive Lymphoproliferative Disorders	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.; Other Names: IdentiClone Dx IGH (IC IGH Dx) Assay
FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders	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.; Other Names: IdentiClone Dx IGH (IC IGH Dx) Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Agreement	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.	Through Study Completion at one year

Collaborators and Investigators

• Sponsor: Invivoscribe, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 2, 2025
• Primary Completion (Estimated): November 6, 2025
• Study Completion (Estimated): December 6, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoproliferative Disorders
• Other Study ID Numbers: IVS-109-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No