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Completed

NCT Number: NCT06112301

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

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.

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Key information

Conditions

B-Cell Lymphoproliferative Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LabPMM GmbH, Hallbergmoos, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • PB specimens that have been frozen prior to extraction

Treatment and study plan

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

Primary outcomes

  1. % 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.

Sponsors and collaborators

Lead sponsor

Invivoscribe, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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