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

December 2, 2024 updated by: Invivoscribe, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hallbergmoos, Germany, 85399
        • LabPMM GmbH
  • Japan
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 210-0821
        • LabPMM GK
  • United States
    • California
      • San Diego, California, United States, 92103
        • Invivoscribe, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
B-Cell Positive Lymphoproliferative Disorders
DNA Samples for subjects with B-Cell Positive Lymphoproliferative Disorders
Diagnostic test: IdentiClone Dx IGH (IC IGH Dx) Assay
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
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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Invivoscribe, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Actual)

November 6, 2024

Study Completion (Actual)

November 6, 2024

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVS-108-001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe