Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Hemorrhage

Adenoma

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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

Immune System Diseases

Hypersensitivity

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Herbal and Botanical

Chrysarobin

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.

Colonic Polyps

Polyps

Intestinal Polyps

Pathological Conditions, Anatomical

The intervention is the integrated system which is composed of psychologist, endoscopy physician, family physician, community outreach, and audiovisuals in the waiting area. In addition to text messages of information, education and communication (IEC) delivered to the participants at the outreach, and education campaigns to mobilize individuals going for screening.

The comparators will be individuals with an average risk of colorectal cancer of both genders attending the randomly selected health centres

participants will be drawn from all public government institutions inside Tabuk city(outreach). The institution head will be requested to give wellness cards to the eligible employee to receive comprehensive testing for free in addition to CRC test in selected public health centres.

Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups

The global burden of colorectal cancer (CRC) incidence among young age groups is rising and overwhelming. This new trend of young-onset CRC incidence is evident in western countries. Unfortunately, Asian countries have shown the same epidemic shift in the past few years. As a consequence, this situation might necessitate revisiting the current screening program in this region.

Saudi Arabia has a two-fold increase in CRC incidence among young age groups in the last 18 years (9.6/100000 for male versus 9.3/100000 for female). This rising incidence ascribed to the lack of a screening program and suggested lowering CRC screening to 40.

The low awareness about risk factors, signs, and symptoms of the disease causes late presentation of CRC cases. Therefore, most presenting cases are associated with a poor prognosis and short survival. Educational and screening programs are, by no means, considered valuable and essential as CRC tends to affect younger age groups.

CRC is cancer that starts in the innermost lining mucosa of the colon or rectum. According to the global cancer Observatory (GCO) 2018, CRC incidence is the third (10.2%) globally, after lung and breast cancers (11.6%). In Saudi Arabia, 2010 report, the incidence was 10.4/100,000 that slightly higher in male groups. Unfortunately, the incidence among young age groups is more than that in countries with high incidence.

Most of the CRCs initially found as small benign growth or projections known as polyps inside the lumen of colorectal space. A polyp is precancerous if it is \>1 cm or the presence of more than two polyps, or if dysplasia present after the polyp removal. There are two main types of polyps: precancerous and hyperplastic polyps or inflammatory polyps, which are not precancerous. The early resection will prevent future cancer development and total cure.

Different lifestyle factors that could increase CRC's risk include lack of regular physical exercise, a diet low in fruit and vegetables, a low-fibre and high-fat diet, diary intake during adolescence, overweight and obesity, alcohol consumption and tobacco use. Adherence to CRC screening is essential to limit CRC cancer incidence and improve population health; and then, health providers need to understand the stages of the disease to recommend effective screening strategies.

List of health centres that randomly allocated to receive the intervention

Effectiveness of an Integrated Colorectal Cancer Screening in Saudi Arabia: A Pragmatic Randomized Trial

Effectiveness of an Integrated Colorectal Cancer Screening System in Saudi Arabia: A Pragmatic Randomized Trial

The comparison of rate positive screening between the intervention and routine care

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
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
Effectiveness of an Integrated Colorectal Cancer Screening in Saudi Arabia: A Pragmatic Randomized Trial	NCT04875793	Colorectal Neop... Colorectal Canc... Colonic Polyp Occult Bleeding	Stool for Occul...	40 Years -	University of Tabuk

Spots Global Cancer Trial Database for occult bleeding