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

NCT06876571 | Not Yet Recruiting

• 1 other identifier: IVS-109-001
• Study Type: observational
• Target: 250
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

T-Cell Lymphoproliferative Disorder

Outcome Measures

Primary Outcomes (1)

• % 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

Study Arms (2)

T-Cell Positive Lymphoproliferative Disorders

FFPE Samples for subjects with T-Cell Positive Lymphoproliferative Disorders

Diagnostic Test: IdentiClone Dx TRG Assay

FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders

FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders

Diagnostic Test: IdentiClone Dx TRG Assay

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.

Also known as: IdentiClone Dx IGH (IC IGH Dx) Assay

FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders; T-Cell Positive Lymphoproliferative Disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• FFPE specimens that were fixed using formalin substitute (ethanol, methanol, etc.)

Sponsors & Collaborators

• Invivoscribe, Inc.: lead

Study Sites (3)

Invivoscribe, Inc.

San Diego, California, 92103, United States

Location

LabPMM GmbH

Hallbergmoos, 85399, Germany

Location

LabPMM GK

Kawasaki-shi, Kanagawa, 210-0821, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Deidentified residual DNA samples

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: June 2, 2025
• Primary Completion: November 6, 2025
• Study Completion: December 6, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); JP (1); US (1)