Evaluating the Effectiveness of Screening Strategies Using Quantitative Versus Qualitative Fecal Immunochemical Test (FIT) to Prioritize Urgency of Colonoscopy Referral - a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Time to diagnosis of advanced colorectal neoplasms
研究概览
简要总结
The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral).
详细描述
It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 50 years and above
排除标准
- •Lower gastrointestinal tract symptoms such as diarrhoea, constipation, per rectal bleeding
- •Personal history of colorectal tumour or cancer
- •Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
研究组 & 干预措施
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Qualitative fecal immunochemical test (Other)
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Colonoscopy (Procedure)
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Cost analysis (Other)
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Anxiety scores (Other)
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Patient satisfaction scores (Other)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Quantitative fecal immunochemical test (Other)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Colonoscopy (Procedure)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Cost analysis (Other)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Anxiety scores (Other)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
干预措施: Patient satisfaction scores (Other)
结局指标
主要结局
Time to diagnosis of advanced colorectal neoplasms
时间窗: 40-90 days from the time of enrolment
Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm
次要结局
- Analysis of screening costs(Up to 90 days following enrolment)
- Patient anxiety levels(Up to 90 days after enrolment)