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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

People in this group with positive fecal immunochemical test results were further examined by colonoscopy.

Participants with positive fecal immunochemical test results were further examined by colonoscopy.

Fecal Immunochemical Test

Ruchen Zhou

Yanqing Li

Hongmei Zhang

Shihuan Wang

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. With progress of developing countries, it is predicted that the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening

Application of Fecal Immunochemical Test for Improving Advanced Adenoma Detection in Colorectal Cancer Screening

The detection rate and positive predictive value of fecal immunochemical test to detect advanced adenoma

The detection rate and positive predictive value of fecal immunochemical test to detect colorectal cancer

The detection rate and positive predictive value of fecal immunochemical test to detect colorectal neoplasms

The People's Hospital of Zhaoyuan City

Shanghe People's Hospital

Shandong University

Clinical Professor

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

A diagnostic device measuring syndecan 2(SDC2) methylation status in stool DNA to detect colorectal cancer

Stool-based SDC2 DNA methylation test

A diagnostic device using immunoturbidimetric methods to measure fecal hemoglobin concentration

quantitative Fecal immunochemical test

Zhaoshen Li, MD

to determine screening value of stool-based SDC2 DNA methylation test for advanced colorectal neoplasia in the asymptomatic Chinese community population.

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 and/or 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 2.6 times and 4.3 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 low/average-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 DNA(sDNA) 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-2(SDC2) 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 16,149 patients. The most accurate single gene was found to be SDC2 with a pooled sensitivity of 83.1% (72.6%, 90.2%) and a specificity of 91.2% (88.6%, 93.2%). A recent study involving 1,110 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 301/359 (83.8%) for CRC, 16/38 (42.1%) for advanced adenomas, and 134/154 (87.0%) for early-stage CRC (stage I-II), while maintaining a specificity of 699/713 (98.0%). 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 low/intermediate-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 Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population

Detection of Advanced Colorectal Neoplasia for Stool DNA in Asymptomatic Chinese Population : A Multi-central Community-based Screening Study

Advanced colorectal neoplasia is defined as a colorectal adenoma or sessile serrated lesion ≥10 mm, adenoma or sessile serrated lesion with tubulovillous or villous histology, adenoma with high-grade dysplasia, traditional serrated adenoma, or presence of colorectal cancer.

The compliance rate of colonoscopy was calculated as the number of recieving colonoscopy divdied the number of accomplishing primary evaluation of APCS, stool DNA or FIT.

Lesions will be confirmed as malignant by histopathologic examination.

Advanced colorectal neoplasia is defined as a colorectal adenoma or sessile serrated lesion, traditional serrated adenoma, hyperplastic polyp ≥10 mm, or colorectal cancer.

Lesions will be confirmed as malignant or precancerous by histopathologic examination.

High-risk subgroup: APCS calculated high-risk or qFIT positive. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination.

Low-risk subgroup: APCS calculated low or medium risk, and qFIT negative. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Gongli Hospital of Shanghai Pudong New Area

Shanghai Songjiang District Central Hospital

Shanghai Jing'an District Central Hospital

Shanghai Yangpu District Central Hospital

People's Hospital of Qingyuan

Guangdong Provincial Hospital of Traditional Chinese Medicine

900 Hospital of the Joint Logistics Team

First Affiliated Hospital of Suzhou Medical College

Affiliated Hospital of Jiangnan University

Traditional Chinese Medicine Hosipital of Kunshan

Ankang Central Hospital

Shandong Cancer Hospital and Institute

Ningjin County Hospital

Changhai Hospital

MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor

Immune System Diseases

Hypersensitivity

Herbal and Botanical

Cola

People in this group will detect fecal hemoglobin concentration by us-qFIT before colonoscopy.

Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.

The us-qFIT and colonoscopy with pathological examination

Ruchen Zhou, MD

Yueyue Li, PhD

Chengxia Liu

Hongjun LiZhang

Xiaozhong Gao

Shuzhang Xu

Bangmao Wang

Yanqing Li, PhD

Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.

Early detection of CRC in a curable stage can reduce mortality but not morbidity. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Although colonoscopy is currently considered the most effective method for detecting advanced adenomas, individuals may be reluctant to undergo colonoscopy due to the uncomfortable feeling and the relatively high cost. Conversely, stool tests are relatively cheap and more readily accepted. Fecal immunochemical test (FIT) is economic and easy to use in colorectal cancer screening. However, the common used qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve the detection rate of colorectal advanced adenoma, Ultra-sensitivity quantitative fecal immunochemical test (us-qFIT) improves technology and can detect fecal hemoglobin in extremely low concentration quantificationally. The investigators design this research to prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenoma.

Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer

Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study

The sensitivity, specificity, positive predictive value and negative predictive value.

Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history, diet and so on.

Shanghai Tongji Hospital, Tongji University School of Medicine

Tianjin Medical University General Hospital

Binzhou Medical University

Weihai Municipal Hospital

People's Hospital of Lixia District of Jinan

Vice president of Qilu Hospital

People in this group will detect hemoglobin in stool before colonoscopy by the new qFIT.

Detect hemoglobin in stool by the new qFIT before colonoscopy, detect colon lesion using colonoscopy and pathological examination.

The new qFIT and colonoscopy with pathological examination

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, the sensitivity of existing quantitative fecal immunochemical test (qFIT) is unsatisfying. A new technology qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin compared with existing commercially available qFIT, is developed and this study will prove the high diagnostic accuracy in detecting colorectal advanced adenoma.

Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. With progress of developing countries, it is predicted that the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Although colonoscopy is currently considered the most effective method for detecting advanced adenomas, individuals may be reluctant to undergo colonoscopy due to the uncomfortable feeling and the relatively high cost of colonoscopy. Conversely, stool tests are relatively cheap and more readily accepted. Annual fecal immunochemical test (FIT), one of the preferred methods of colorectal cancer screening, is economic and easy to use. However, the existing commercially available qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve diagnostic accuracy in detecting colorectal advanced adenoma, an improved technology of qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin in stool compared with existing commercially available qFIT, is developed. The investigators design this research to prove the diagnostic accuracy of the new qFIT in detecting colorectal advanced adenoma.

A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma

A New Quantitative Fecal Immunochemical Test Can Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma.

Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT, age , sex, colorectal cancer family history, diet and so on.

People in this group will use four kind of fecal occult blood test, including quantitative and qualitative method, to detect Hb in stool before colonoscopy.

Detect Hb in stool by 4 kind of FOBT and detect colon lesion using colonoscopy and pathological examination.

4 kind of FOBT and colonoscopy with pathological examination

Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related death can be prevented through fecal occult blood test screening. Because of economic and high sensitivity, fecal immunochemical test is recommended for screening population of CRC. The purpose of this study is to compare the accuracy of 4 different fecal occult blood testing in medium and high risk screening population in Chinese.

Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number of cancer-associated mortality. CRC screening has been shown to be effective in reducing the incidence of, and mortality from, CRC. There are several recommended screening options for screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT) .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced colorectal neoplasia but also has several disadvantages, including higher cost and poorer compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in screening population of CRC in Chinese. To add to the evidence on FIT performance characteristics for detection of CRC, the investigators design this research to compare qFIT with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them is chemical and immunologic combined detection）in medium and high risk screening population.

A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening

A Comparison of Quantitative Fecal Immunochemical Test and Qualitative Fecal Occult Blood Test for Colorectal Cancer Screening in Medium and High Risk Screening Population

The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC.

The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.

The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma.

Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on.

Explore the cost-benefit ratio of one or two-sample of qFIT.

Calculate false positive rate of the 4 kind of FOBTs. and count the case number of inflammatory bowel disease, colonic diverticulitis, hemorrhoids, upper gastrointestinal disease or medical factors that cause false positive of qFIT.

Count sensitivity and specificity with or without patients who take aspirin or other anticoagulants.

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.

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.

This test measures the amount of blood within the submitted stool specimen

Qualitative fecal immunochemical test

This test detects presence or absence of blood within a submitted stool specimen.

Quantitative fecal immunochemical test

Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.

Colonoscopy

Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.

Cost analysis

Hospital Anxiety and Depression Scale (HADS) questionnaire

Anxiety scores

A 5-point patient satisfaction score will be documented at each patient visit related to screening.

Patient satisfaction scores

April C Roslani, MBBCh

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).

It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.

Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral

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

Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm

Total costs incurred as a result of the screening process

As measured by the Hospital Anxiety and Depression Scale (HADS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening	NCT05200611	Colorectal Canc... Colorectal Neop... Colorectal Aden...	Fecal Immunoche...	50 Years - 75 Years	Shandong University
A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population	NCT04786704	Colorectal Canc... Colorectal Neop... Advanced Adenom... Adenoma Serrated Lesion	Stool-based SDC... quantitative Fe...	45 Years - 75 Years	Changhai Hospital
Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer	NCT04856423	Colorectal Neop...	The us-qFIT and...	50 Years - 75 Years	Shandong University
A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma	NCT04473677	Colorectal Aden... Colorectal Neop... Colorectal Canc...	The new qFIT an...	50 Years - 75 Years	Shandong University
A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening	NCT04454099	Colorectal Canc...	4 kind of FOBT ...	50 Years - 75 Years	Shandong University
A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population	NCT04786704	Colorectal Canc... Colorectal Neop... Advanced Adenom... Adenoma Serrated Lesion	Stool-based SDC... quantitative Fe...	45 Years - 75 Years	Changhai Hospital
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral	NCT02037646	Colorectal Canc...	Qualitative fec... Quantitative fe... Colonoscopy Cost analysis Anxiety scores Patient satisfa...	50 Years -	University of Malaya

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