IdentiClone Dx IGHアッセイの精度評価のための重要な臨床研究

基本情報

NCT ID

NCT06112301

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

250

治験依頼者名

Invivoscribe, Inc.

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)