ChiCTR2100045739
Active, not recruiting
Early Phase 1
新型胎儿游离核酸多维整合分析技术在无创产前筛查中的临床应用
自筹3 sites in 1 country1,000 target enrollmentStarted: January 1, 2021Last updated:
Overview
- Phase
- Early Phase 1
- Status
- Active, not recruiting
- Sponsor
- 自筹
- Enrollment
- 1,000
- Locations
- 3
- Primary Endpoint
- 染色体拷贝数变异检测
Overview
Brief Summary
针对高风险妊娠人群,通过无创产前检测技术对多种染色体非整倍体、微缺失微重复、及单基因遗传病的胎儿患病风险进行提示,与产前诊断结果、妊娠结局和出生后随访结果进行比较,考察检测技术的灵敏度、特异性、阳性预测值、阴性预测值等指标。对各类遗传疾病的发病率、胎儿结构发育异常指征等数据进行分析和总结,形成科研结果。根据该无创产前检测技术对妊娠结局的影响,对其临床价值进行评估。
Study Design
- Study Type
- 筛查
- Primary Purpose
- 连续入组
- Masking
- N/a
Eligibility Criteria
- Ages
- 20 to — (—)
- Sex
- Female
Inclusion Criteria
- •1.20 周岁以上的孕妇;
- •2.孕周>=12+0 周;
- •4.同意参加本次临床试验,并接受至少一项分子诊断(如产前诊断、流产物或脐带血诊断);
- •5.高风险妊娠且需要进行产前诊断的,包括以下情形:
- •(1)产前超声检查显示胎儿结构发育异常;
- •(2)传统 NIPS 提示高风险;
- •(3)血清学等产前筛查提示高风险;
- •(4)临床医师认为其他疑似遗传性疾病的适用情形 (如不明原因反复流产等)。
Exclusion Criteria
- •1.夫妇一方有或疑似有染色体异常;
- •2.一年内接受过异体输血、移植手术、异体细胞治疗等;
- •3.有基因病遗传家族史或提示胎儿罹患基因病高风险;
- •4.孕期合并恶性肿瘤;
- •5.临床医师认为明显影响结果准确性的其它情形。
Arms & Interventions
连续入组
无
Outcomes
Primary Outcomes
染色体拷贝数变异检测
基因测序
核型分析
产前超声检查
染色体芯片
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
Loading locations...
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