NQMD-CS: A Prospective Interventional Study to Evaluate the Feasibility of a Blood-Based Multi-Cancer Early Detection Test in an Asymptomatic Screening Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,250
- 试验地点
- 2
- 主要终点
- Feasibility of MCED in the intended use setting
研究概览
简要总结
This is a prospective, multicenter screening cohort study designed to evaluate the feasibility of a blood-based multi-cancer early detection (MCED) test in an asymptomatic screening population. Eligible participants will undergo blood-based MCED testing, standard cancer screening as appropriate, and 1-year active follow-up. Participants with positive MCED results or highly suspicious findings from standard screening will undergo diagnostic evaluation to determine cancer status, enabling a more accurate assessment of the test's clinical performance.
详细描述
This study consists of four stages: recruitment and enrollment, testing and screening, diagnostic evaluation, and follow-up.
Approximately 1,250 participants will be recruited through community-based recruitment and invitations from family physicians to enhance the representativeness of the screening population. Peripheral blood will be collected from each participant for blood-based multi-cancer early detection (MCED) testing, which is designed to detect signals associated with five cancer types, including lung, colorectal, liver, gastric, and esophageal cancers. Participants will also undergo usual care and standard single-cancer screening, as appropriate, based on their individual cancer risk assessment.
During the diagnostic stage, participants with positive MCED results will undergo diagnostic evaluation guided by the cancer site indicated by the MCED test. Participants with highly suspicious findings from standard screening or usual care will also undergo diagnostic evaluation according to applicable clinical guidelines. The number and types of diagnostic tests and procedures required to achieve diagnostic resolution will be recorded to assess the downstream diagnostic burden and safety of MCED.
During the follow-up stage, cancer status will be actively followed. For participants diagnosed with cancer, relevant clinical information will be collected.
In addition to the assessment of safety and performance, participant-reported outcome questionnaires will be administered at baseline, upon delivery of screening results, upon completion of the diagnostic evaluation, and at the 1-year follow-up to assess the psychological impact of MCED testing.
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
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.40-74 years old; 2.Able to provide a written informed consent; 3.Willing to comply with all part of the protocol procedures.
排除标准
- •With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen;
- •Have definite contraindications of cancer screening examination and diagnostic procedures;
- •Unable to comply with the protocol procedures;
- •Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date;
- •Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrine therapy for cancer is not an exclusion criterion;
- •Recipients of anti-tumor therapy within 30 days prior to screen;
- •Pregnancy or lactating women;
- •Recipients of organ transplant or prior bone marrow transplant or stem cell transplant;
- •Recipients of blood transfusion within 7 days prior to screen;
- •With autoimmune diseases;
- •Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw;
- •Unsuitable for this trial determined by the researchers.
研究组 & 干预措施
MCED-screening
MCED results are returned to investigators and participants. Participants with a cancer signal undergo clinician-guided diagnostic assessment to confirm or rule out cancer
干预措施: MCED (Diagnostic Test)
结局指标
主要结局
Feasibility of MCED in the intended use setting
时间窗: From enrollment to the Follow-up at 1 year
Descriptive statistics will be used to summarize the number of the five pre-specified cancers diagnosed by MCED.
Safety of MCED in the intended use setting
时间窗: From enrollment to the Follow-up at 1 year
Descriptive statistics will be used to summarize the time to diagnostic resolution following receipt of a positive MCED result and the number and types of diagnostic tests and procedures performed during the diagnostic evaluation.
次要结局
- Performance of MCED in the intended use setting.(From enrollment to the Follow-up at 1 year)
- Tissue-of-origin accuracy of MCED(From enrollment to the Follow-up at 1 year)
- Participant-reported anxiety impact(From enrollment to the Follow-up at 1 year)
- Participant-reported health related quality of life (HRQoL)(From enrollment to the Follow-up at 1 year)