Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- % Agreement
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •PB specimens that have been frozen prior to extraction
结局指标
主要结局
% Agreement
时间窗: 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.
次要结局
未报告次要终点