Should Colorectal Cancer screening be done in Asymptomatic Indians: A Pan-India multicentre study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,500
- 试验地点
- 8
- 主要终点
- To evaluate the prevalence of advanced colorectal neoplasia or colorectal cancer in asymptomatic healthy adults aged 50-75 years by adopting a modified risk score based screening strategy in India.
研究概览
简要总结
Rationale of study: The true prevalence of advanced colorectal neoplasm in an asymptomatic healthy population is unknown. We look to explore the prevalence, and cost effectiveness and devise a rational screening strategy for CRC in India using a validated risk score based approach.
Hypothesis/Research Question:
· What is the true prevalence of advanced colorectal neoplasia or CRC in asymptomatic healthy individuals in the general population?
· What is the benefit of adopting a risk score based screening strategy in India?
**Objective:**To primarily evaluate the prevalence of advanced colorectal neoplasia or colorectal cancer in asymptomatic healthy adults aged 50-75 years by adopting a modified risk based scoring strategy in India. Secondary outcomes would include knowing the prevalence of all forms of colorectal polyps, evaluating the screening strategy’s cost effectiveness and identifying risk factors’ contribution.
Expected Outcomes: To know the true prevalence of advanced colorectal neoplasia/colorectal cancer in asymptomatic healthy adults in India and devise a rational screening strategy for CRC in India.
Methods:All asymptomatic healthy adults aged 50-75 would be invited to participate in this screening study. Exclusions would include any prior diagnosis of cancer, family history of CRC, Inflammatory Bowel Disease**,** Colonoscopy or gFOBT or FIT or Sigmoidoscopy/ Barium study done within the last 10 years**,** any recent onset of lower gastrointestinal tract symptoms**,** previous gastrointestinal surgery and unlikely to be compliant or unable to give informed consent.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy asymptomatic adults aged between 50-75 years.(Absence of following symptoms: weight loss, persistent fever, anaemia, diarrhoea, rectal bleeding, constipation (recent onset within past 1 year), persistent abdominal pain).
- •Written Informed consent.
排除标准
- •1.Prior diagnosis of cancer 2.Family history of CRC: those with recognised familial genetic syndromes;those having FDRs with documented advanced adenomas.
- •3.Inflammatory Bowel Disease 4.Colonoscopy, gFOBT,FIT, sigmoidoscopy, barium enema done within the last 10 years 5.Recent onset of lower gastrointestinal tract symptoms (bleeding, change in bowel habit, abdominal pain, weight loss, bloating, anaemia) causing healthcare attendance in the previous 12 months.
- •6.Significant comorbidity (American Society of Anaesthesiologists class III or greater) 7.Previous gastrointestinal surgery 8.Participation in any other clinical trial in the previous 3 months 9.A person unlikely to be compliant or unable to give informed consent.
结局指标
主要结局
To evaluate the prevalence of advanced colorectal neoplasia or colorectal cancer in asymptomatic healthy adults aged 50-75 years by adopting a modified risk score based screening strategy in India.
时间窗: Baseline, Follow up 1st year, Follow up 2nd year
次要结局
- To evaluate the prevalence of all forms of colorectal polyps in asymptomatic healthy adults.(Baseline, Follow up 1st year, Follow up 2nd year)
- To evaluate the cost effectiveness or benefit of adopting a risk score based screening strategy.(Baseline, Follow up 1st year, Follow up 2nd year)
- To identify the contribution of each risk factor for occurrence of advanced colorectal neoplasia or colorectal cancer.(Baseline, Follow up 1st year, Follow up 2nd year)
研究者
Dr Vineet Ahuja
All India Institute of Medical Sciences, Delhi