Colorectal Adenoma
Conditions
Keywords
advanced colorectal adenoma, colonoscopy, sigmoidoscopy, fecal immunochemical test
Brief summary
The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.
Detailed description
The investigators will evaluate the efficacy of FITS for the detection of advanced colorectal neoplasia compared to colonoscopy. This study was designed as multicenter randomized interventional study. The expected period are 36months. A total 13 tertiary hospitals will participate in the study. Subjects will be randomly allocated to FITS group and colonoscopy group. Subjects who undergo FITS will be performed by following colonoscopy to confirm the efficacy of FITS. In colonoscopy group, subjects as a control group would be performed colonoscopy.
Interventions
PROCEDUREFIT-sigmoidoscopy
Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy
PROCEDUREColonoscopy
Advanced colorectal adenoma detection by colonoscopy
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Asymptomatic subjects aged 45 - 75 years * Subjects who will give the written consent
Exclusion criteria
* Subjects with past history of colorectal cancer * Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC) * Subjects with familial history of colorectal cancer more than 2 familial member in direct line * Subjects with inflammatory bowel disease(IBD) * Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification * Subjects with past history of colectomy * Subjects with history of colonoscopy within 5 years * Subjects with history of sigmoidoscopy within 3 years * Subjects with history of CT colonoscopy within 10 years * Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Advanced colorectal adenoma detection rate between two groups | on 7 days after intervention | We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| specificity of fecal immunochemical test for advanced colorectal adenoma | on 7days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported. |
| positive predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer | on 7 days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported. |
| negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer | on 7 days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported. |
| specificityof fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer | on 7 days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported. |
| positive predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer | on 7 days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported. |
| negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer | on 7 days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported. |
| Sensitivity of fecal immunochemical test for advanced colorectal adenoma | on 7days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported. |
| Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer | on 7 days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported. |
| Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer | on 7 days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported. |
| positive predictive valueof fecal immunochemical test for advanced colorectal adenoma | on 7days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported. |
| negative predictive value of fecal immunochemical test for advanced colorectal adenoma | on 7days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported. |
| specificity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer | on 7 days after intervention | We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The characteristic of polyps which would be missed by sigmoidoscopy | on 7 days after intervention | We will evaluated the characteristic of polyps which would be missed by sigmoidoscopy on 7 days after sigmoidoscopy when pathologic diagnosis would be reported. |
| Cut off value of fecal immunochemical test that could have equal detection rate for colorectal cancer with colonoscopy. | on 7 days after intervention | We will evaluate the cut off value of fecal immunochemical test that could have equal detection rate for colorectal cancer with colonoscopy on 7 days after colonoscopy when pathologic diagnosis would be reported. |
| Sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy | on 7 days after intervention | We will evaluate sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy. |
| Adenoma detection rate and sessile serrated polyp detection rate | on 7 days after intervention | We will evaluate adenoma detection rate and sessile serrated polyp detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported. |
| Missing adenoma rate of sigmoidoscopy | on 7 days after intervention | We will evaluate missing adenoma rate of sigmoidoscopy on 7 dyas after sigmoidoscopy when pathologic diagnosis would be reported. |
Countries
South Korea
Contacts
Primary ContactHyun-Soo Kim, M.D., ph D.
Backup ContactHong Jun Park, M.D.
Outcome results
None listed