A Prospective, Interventional Study to Assess the Clinical Performance of the APOL1 Genotyping Clinical Trial Assay in the Intended Use Population and Environment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Assessment of APOL1 genotype result within the study population (G1/G2/G0), for participants' specimens tested using the APOL1 Genotyping CTA
研究概览
简要总结
Clinical Performance Study SP2024001, is a prospective, interventional study to assess the clinical performance of the APOL1 Genotyping Clinical Trial Assay (CTA) in the intended use population and environment. The study will use the APOL1 Genotyping CTA to test deoxyribonucleic acid (DNA) extracted from blood specimens to identify individuals who are homozygous or compound heterozygous for apolipoprotein L1 (APOL1) high-risk genotypes (G1 and G2).The individuals who are identified as being homozygous or compound heterozygous for the APOL1 high-risk genotypes are candidates for enrolment onto an pharmaceutical company-sponsored, Phase 2b clinical trial which is investigating the safety and efficacy of a synthetic antisense oligonucleotide (ASO) for the treatment of APOL1-mediated kidney disease (AMKD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Almac Diagnostic Services receives de-identified specimens only for inclusion in the clinical performance study. The clinical trial protocol describes the blinding and un-blinding procedures for the clinical trial and this responsibility lies with the pharmaceutical clinical trial sponsor.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study participants must be identified as a potential candidate for the pharmaceutical company- sponsored clinical trial by their physician based on the clinical trial inclusion criteria.
- •Study participant has agreed to and signed the clinical trial Informed Consent Form (inclusive of risks related to the APOL1 Genotyping CTA).
- •The study participant's specimen must be distributed to the device test site accompanied by a complete Test Request Form signed by the appropriate clinical trial site personnel.
- •All participant specimens must meet predetermined specifications (e.g., undamaged, appropriate volume, appropriate specimen type, appropriate disease indication) for acceptance for testing by the device test site in accordance with established procedures.
排除标准
- •Study participants will be excluded as a potential candidate for the pharmaceutical company -sponsored clinical trial by their physician based on the clinical trial exclusion criteria as assessed at screening visit
- •The study participant has not agreed to and signed the (Clinical Trial) Informed Consent Form.
- •The study participant's specimen is distributed to the device test site without a complete Test Request Form.
- •The study participant's specimen did not meet predetermined specifications for acceptance for testing by the device test site in accordance with established procedures.
研究组 & 干预措施
APOL1 Genotyping
All study participants will submit a blood specimen for APOL1 Genotyping CTA screening. The APOL1 Genotyping CTA will identify individuals who are homozygous or compound heterozygous for apolipoprotein L1 (APOL1) high-risk genotypes (G1 and G2). The individuals who are identified as being homozygous or compound heterozygous for the APOL1 high-risk genotypes are candidates for enrolment onto an pharmaceutical company-sponsored, Phase 2b clinical trial which is investigating the safety and efficacy of a synthetic antisense oligonucleotide (ASO) for the treatment of APOL1-mediated kidney disease (AMKD).
干预措施: APOL1 Genotyping (Diagnostic Test)
结局指标
主要结局
Assessment of APOL1 genotype result within the study population (G1/G2/G0), for participants' specimens tested using the APOL1 Genotyping CTA
时间窗: Through study completion, approximately 1 year
To utilize the APOL1 Genotyping CTA as a screening test to identify participants homozygous or compound heterozygous for high risk APOL1 genotypes (G1/G2) for inclusion in a Ph 2b trial
次要结局
- Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet device turn-around time (TAT)(Through study completion, approximately 1 year)
- Percentage of specimens submitted for APOL1 Genotyping CTA testing which meet laboratory TAT(Through study completion, approximately 1 year)
- Percentage of specimens submitted for APOL1 Genotyping CTA testing for which the device 'test was not ordered accurately (TNOA)(Through study completion, approximately 1 year)
- Percentage 'Specimens Not Accepted (SNA)' by the clinical laboratory(ies) for APOL1 Genotyping CTA testing(Through study completion, approximately 1 year)
- Percentage of Quality Control Failures(Through study completion, approximately 1 year)
- Percentage of corrected reports(Through study completion, approximately 1 year)
- Percentage of updated reports(Through study completion, approximately 1 year)
- Percentage homozygous or compound heterozygous for APOL1 high risk genotypes within the study population(Through study completion, approximately 1 year)