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

NCT06112301 | Completed

• 1 other identifier: IVS-108-001
• Study Type: observational
• Target: 250
• Locations: 3 countries
• Sites: 3

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.

Conditions

B-Cell Lymphoproliferative Disorder

Outcome Measures

Primary Outcomes (1)

• % Agreement

  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.

  Through Study Completion at one year

Study Arms (2)

B-Cell Positive Lymphoproliferative Disorders

DNA Samples for subjects with B-Cell Positive Lymphoproliferative Disorders

Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay

B-Cell Negative Lymphoproliferative Disorders

DNA Samples for subjects suspected of B-Cell Positive Lymphoproliferative Disorders with negative B-Cell Clonality testing

Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay

Interventions

IdentiClone Dx IGH (IC IGH Dx) Assay DIAGNOSTIC_TEST

The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease

B-Cell Negative Lymphoproliferative Disorders; B-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 B-Cell Lymphoproliferative disorders or suspected of B-Cell Lymphoproliferative disorders with negative B-Cell Clonality Testing results

You may qualify if:

• DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl
• DNA extracted from PB specimens no more than 7 days
• DNA stored at -15°C to -30°C up to 5 years
• Donor Age: ≥ 18
• For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:
• ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis
• B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)
• For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease

You may not qualify if:

• \. PB specimens that have been frozen prior to extraction

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: October 20, 2023
• First Posted: November 1, 2023
• Study Start: January 2, 2024
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

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