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

NCT06112301 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-12-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Invivoscribe, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-11-06
Completion
2024-11-06

Countries

  • United States
  • Germany
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112301 on ClinicalTrials.gov