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临床试验/ACTRN12621000092897
ACTRN12621000092897进行中(未招募)未知

The SCRIPT (Snp Cancer Risk Prediction): an RCT on the effect of a genomic risk score delivered in primary care on risk-appropriate colorectal cancer screening

The University of Melbourne0 个研究点目标入组 274 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
274

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
45 Years 至 70 Years(—)
性别
All

入选标准

  • Eligible participants for the trial are aged between 45 and 70 years old
  • Participants able to read and write English and competent to give informed consent
  • Participants who are contactable over the next 12 months for the study follow-up
  • Inclusion restricted to patients that are potentially due for some form of bowel cancer screening within the next 12 months, i.e.:
  • oAll patients aged 45-50 will be, included as we will not know their genomic risk pre-recruitment. Some will be at increased risk and therefore be recommended early screening in the study;
  • oThose aged 50-70 years of age who report not having an FOBT in last 2 years.

排除标准

  • Patients with a previous diagnosis of colorectal cancer are excluded
  • Patients with at least one grandparent was born in Africa or is of African ethnicity are ineligible to participate due to the specificity of the DNA test
  • Patients with a known genetic predistortion to colorectal cancer or a family history of cancer that requires referral for assessment of a genetic predisposition to colorectal cancer are excluded (according to the NHMRC guidelines). This includes:
  • oThose confirmed as carrying a pathogenic mutation in a gene associated with a high-risk familial syndrome
  • oThose with a relative confirmed as carrying a pathogenic mutation in a gene associated with a high-risk familial syndrome, who have not themselves been tested
  • oThose with or those with a relative with familial adenomatous polyposis
  • oThose with a relative with multiple colorectal cancers
  • oThose with at least three first-degree or second-degree relatives with a Lynch syndrome-related cancer (colorectal, endometrial, ovarian, stomach, small bowel, renal pelvis or ureter, biliary tract, brain) with at least one diagnosed before age 55 years).
  • Patients with recent rectal bleeding or inflammatory bowel disease are excluded and referred for assessment by their GP because they may require colonoscopy as a diagnostic rather than screening procedure.

研究者

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