Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786704
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2021-03-02
Brief Title:
A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
Detection of Advanced Colorectal Neoplasia for Stool DNA in Asymptomatic Chinese Population A Multi-central Community-based Screening Study
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
to determine screening value of stool-based SDC2 DNA methylation test for advanced colorectal neoplasia in the asymptomatic Chinese community population
Detailed Description:
In China colorectal cancer CRC remains to be the leading cancer of the digestive system According to nationwide cancer statistics using population-based cancer registry data in China age-standardized incidence rate of CRC and age-standardized mortality rate increased significantly from 2000 to 2015 It induces a substantial financial burden in terms of healthcare utilization and quality-adjusted life years QALY lost Fecal Occult Blood Tests FOBT and colonoscopy have been proposed as the main primary screening modalities for asymptomatic subjects by international guidelines and Asia Pacific Consensus Statements Nevertheless shortage and uneven distribution of colonoscopy resources combined with huge population base consisted of the current situation in China Previous population-based CRC screening programs usually employed questionnaires andor FOBT to assess high-risk groups and recommended colonoscopy This algorithm faced difficulties such as complex traditional questionnaires low colonoscopy adherence and a high false-positive rate When the Coronavirus disease 2019 pandemic further limited the implementation of colonoscopy the contradictions developed more acute
A Hong Kong group had designed and validated a colorectal cancer risk scoring system based on age gender smoking history and family history through the results of screening in 11 Asia-Pacific cities The Asia-Pacific Colorectal Screening APCS score was more concise and divided the population into three categories low risk intermediate risk and high risk Compared with the low-risk population the probability of advanced colorectal neoplasia in intermediate-risk and high-risk population increased by 26 times and 43 times respectively Because of simplicity and efficiency it was recommended by Asia-Pacific screening guidelines and several guidelines in China Another APCS related multi-center study indicated that by selecting high-risk subjects and lowaverage-risk subjects with a positive fecal immunochemical test FIT for colonoscopy the colonoscopy workload could be reduced by 50 compared with the strategy of primary colonoscopy in those same subjects All these experiences deserved to be drawn on during the post-pandemic era
The recent decade has witnessed a rapid development of non-invasive biomarkers to detect CRC Stool DNAsDNA Testing is a novel screening test for CRC using molecular techniques to identify CRC-relevant biomarkers in stool One of its toolkits Multitarget Stool DNA Testing FIT-DNA was first approved by the FDA in 2014 for its application in clinical practice which has been widely promoted in the United States Subsequently it was endorsed by multiple societies as one of the recommended screening tests
Recently a stool test of methylated Syndecan-2SDC2 has been developed as a fecal-DNA product targeted to improve the diagnostic accuracy of CRC screening A meta-analysis of previous clinical studies reporting the accuracy of stool DNA methylation tests in detecting CRC included 46 studies totaling 16149 patients The most accurate single gene was found to be SDC2 with a pooled sensitivity of 831 726 902 and a specificity of 912 886 932 A recent study involving 1110 subjects from 2017 to 2018 by three Chinese tertiary hospitals assessed the performance of the SDC2 sDNA test The sensitivity of the SDC2 sDNA test was 301359 838 for CRC 1638 421 for advanced adenomas and 134154 870 for early-stage CRC stage I-II while maintaining a specificity of 699713 980 Nevertheless there were limitations in the design of these original studies For instance most involved small hospital-based CRC cases and controls that might not fill the knowledge gap between population screening Additional clinical trials are required to further validate its diagnostic accuracy in other populations especially community-setting
Potential participates would be recruited via community public communication The subjects would be asked to fill in a concise questionnaire obtained through a public WeChat account after informed consent Basic information would be acquired while APCS score and correspondent risk categories would be calculated automatically After sampling education stool collection devices of sDNA and quantitative fecal immunochemical test qFIT would be distributed to all subjects Two samples of stool from single defecation would be requested to put into the two collection devices according to instructions respectively by the subjects themselves at home
Efforts would be made by the public WeChat account and the community staff to urge samples recover from subjects as quickly as possible prefer within 24h after defecation Community staff would deliver the samples qualified in the initial evaluation to the standardized laboratory for testing as quickly as possible If APCS be evaluated high-risk or any of qFIT or sDNA tests positive the risk of the subject would be considered increased Colonoscopy would be strongly recommended and priority and rapid arrangement would be made in the corresponding center For subjects with lowintermediate-risk APCS and negative qFIT and sDNA the project team also encourages the subjects to accept colonoscopy on the basis of a clear understanding of benefits and risks We would help to arrange colonoscopy as early as possible
All colonoscopy examinations will be performed by experienced endoscopists while monitoring quality of colonoscopy bowel preparation cecal intubation rate and withdrawal time Full-time recording personnel would be arranged to follow up and record the relevant information of colonoscopy For the subjects diagnosed with colorectal cancer the postoperative diagnosis and tumor-node-metastasis TNM staging of the subjects would be retrieved
A Hong Kong group had designed and validated a colorectal cancer risk scoring system based on age gender smoking history and family history through the results of screening in 11 Asia-Pacific cities The Asia-Pacific Colorectal Screening APCS score was more concise and divided the population into three categories low risk intermediate risk and high risk Compared with the low-risk population the probability of advanced colorectal neoplasia in intermediate-risk and high-risk population increased by 26 times and 43 times respectively Because of simplicity and efficiency it was recommended by Asia-Pacific screening guidelines and several guidelines in China Another APCS related multi-center study indicated that by selecting high-risk subjects and lowaverage-risk subjects with a positive fecal immunochemical test FIT for colonoscopy the colonoscopy workload could be reduced by 50 compared with the strategy of primary colonoscopy in those same subjects All these experiences deserved to be drawn on during the post-pandemic era
The recent decade has witnessed a rapid development of non-invasive biomarkers to detect CRC Stool DNAsDNA Testing is a novel screening test for CRC using molecular techniques to identify CRC-relevant biomarkers in stool One of its toolkits Multitarget Stool DNA Testing FIT-DNA was first approved by the FDA in 2014 for its application in clinical practice which has been widely promoted in the United States Subsequently it was endorsed by multiple societies as one of the recommended screening tests
Recently a stool test of methylated Syndecan-2SDC2 has been developed as a fecal-DNA product targeted to improve the diagnostic accuracy of CRC screening A meta-analysis of previous clinical studies reporting the accuracy of stool DNA methylation tests in detecting CRC included 46 studies totaling 16149 patients The most accurate single gene was found to be SDC2 with a pooled sensitivity of 831 726 902 and a specificity of 912 886 932 A recent study involving 1110 subjects from 2017 to 2018 by three Chinese tertiary hospitals assessed the performance of the SDC2 sDNA test The sensitivity of the SDC2 sDNA test was 301359 838 for CRC 1638 421 for advanced adenomas and 134154 870 for early-stage CRC stage I-II while maintaining a specificity of 699713 980 Nevertheless there were limitations in the design of these original studies For instance most involved small hospital-based CRC cases and controls that might not fill the knowledge gap between population screening Additional clinical trials are required to further validate its diagnostic accuracy in other populations especially community-setting
Potential participates would be recruited via community public communication The subjects would be asked to fill in a concise questionnaire obtained through a public WeChat account after informed consent Basic information would be acquired while APCS score and correspondent risk categories would be calculated automatically After sampling education stool collection devices of sDNA and quantitative fecal immunochemical test qFIT would be distributed to all subjects Two samples of stool from single defecation would be requested to put into the two collection devices according to instructions respectively by the subjects themselves at home
Efforts would be made by the public WeChat account and the community staff to urge samples recover from subjects as quickly as possible prefer within 24h after defecation Community staff would deliver the samples qualified in the initial evaluation to the standardized laboratory for testing as quickly as possible If APCS be evaluated high-risk or any of qFIT or sDNA tests positive the risk of the subject would be considered increased Colonoscopy would be strongly recommended and priority and rapid arrangement would be made in the corresponding center For subjects with lowintermediate-risk APCS and negative qFIT and sDNA the project team also encourages the subjects to accept colonoscopy on the basis of a clear understanding of benefits and risks We would help to arrange colonoscopy as early as possible
All colonoscopy examinations will be performed by experienced endoscopists while monitoring quality of colonoscopy bowel preparation cecal intubation rate and withdrawal time Full-time recording personnel would be arranged to follow up and record the relevant information of colonoscopy For the subjects diagnosed with colorectal cancer the postoperative diagnosis and tumor-node-metastasis TNM staging of the subjects would be retrieved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None