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| Name | Class |
|---|---|
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Binzhou Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Us-qFIT group | People in this group will detect fecal hemoglobin concentration by us-qFIT before colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The us-qFIT and colonoscopy with pathological examination | Diagnostic Test | Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination. |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of us-qFIT to diagnose colorectal advanced adenoma. | The sensitivity, specificity, positive predictive value and negative predictive value. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of us-qFIT to diagnose colorectal cancer. | The sensitivity, specificity, positive predictive value and negative predictive value. | 24 months |
| The accuracy of us-qFIT to diagnose high-risk adenoma. |
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Inclusion Criteria:
Exclusion Criteria:
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Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria from the 5 hospitals were enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruchen Zhou, MD | Contact | 15949702165 | sdlwzrc@126.com | |
| Yueyue Li, PhD | Contact | 18560089751 | lyynqj@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li, PhD | Qilu Hospital of Shandong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Binzhou Medical University Hospotal | Recruiting | Binzhou | Shandong | China |
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| Weihai Municipal Hospital |
| OTHER |
| People's Hospital of Lixia District of Jinan | UNKNOWN |
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Stool sample
The sensitivity, specificity, positive predictive value and negative predictive value.
| 24 months |
| Develop a predictive model of advanced colorectal neoplasms which includes the value of us-qFIT. | Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history, diet and so on. | 24 months |
| People's Hospital of Lixia District of Jinan | Recruiting | Jinan | Shandong | 250012 | China |
|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
|
| Weihai Municipal Hospital | Recruiting | Weihai | Shandong | China |
|
| Shanghai Tongji Hospital, Tongji University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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