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

Completed

• Conditions: B-Cell Lymphoproliferative Disorder
• Interventions: Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay

• Registration Number: NCT06112301
• Lead Sponsor: Invivoscribe, Inc.

Brief Summary

This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-01
• Study Start: 2024-01-02
• Primary Completion: 2024-11-06
• Study Completion: 2024-11-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl

2. DNA extracted from PB specimens no more than 7 days

3. DNA stored at -15°C to -30°C up to 5 years

4. Donor Age: ≥ 18

5. For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:

   1. ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis
   2. B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)

6. For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease

Exclusion Criteria

1. PB specimens that have been frozen prior to extraction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B-Cell Positive Lymphoproliferative Disorders	IdentiClone Dx IGH (IC IGH Dx) Assay	DNA Samples for subjects with B-Cell Positive Lymphoproliferative Disorders
B-Cell Negative Lymphoproliferative Disorders	IdentiClone Dx IGH (IC IGH Dx) Assay	DNA Samples for subjects suspected of B-Cell Positive Lymphoproliferative Disorders with negative B-Cell Clonality testing

Primary Outcome Measures

Name	Time	Method
% Agreement	Through Study Completion at one year	Agreement between the results of the Invivoscribe IdentiClone Dx IGH Assay and the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq by assessing the positive and negative percent agreement between the two assays.

Trial Locations

Locations (3)

Invivoscribe, Inc.; 🇺🇸 San Diego, California, United States

LabPMM GmbH; 🇩🇪 Hallbergmoos, Germany

LabPMM GK; 🇯🇵 Kawasaki-shi, Kanagawa, Japan