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National Colorectal Polyp Care (NCPC)

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ClinicalTrials.gov Identifier: NCT03712059
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Brief Summary:
This study has three main purposes:diagnose: the first purpose is to evaluate the screening value of combintion of the Asia-Pacific Colorectal Screening (APCS) score and immunochemical fecal occult blood test (FIT) on early detection of colorectal cancer/precancerous lesions in Chinese population; resection: the second objective is to investigate the complete resection rate of colorectal adenoma and risk factors of incomplete resection in China; identification and classification: the third objective is to initially establish an artificial intelegence-assissted recognition and classification system of polyp based on deep learning.

Condition or disease Intervention/treatment
Colorectal Polyp Diagnostic Test: FIT test and colonoscopy Diagnostic Test: Polypectomy and biopsy Diagnostic Test: Classification

Detailed Description:

This study is a multi-center cross-sectional survey and diagnostic test led by the National Clinical Research Center for Digestive Disease (Shanghai) (Department of Gastroenterology, Changhai Hospital, Second Military Medical University), which is conducted at about 200 digestive endoscopy centers nationwide in China, with the expectation of including 25,000 patients (200,000 screening and 5,000 adenoma resection). The basic characteristics of patients, bowel preparation method and quality, and related information of colonoscopy are recorded in detail. According to the research purpose, the whole project can be divided into three sections.

  1. Screening section: All patients receive FIT test and colonoscopy, whose age, sex, family history, smoking history, body mass index (BMI), and diabetes history of the patients are collected by researchers through pad, equipped with a specially designed database and app. Using colonoscopy results as the gold standard, the screening value of the APCS score and FIT test for the Chinese population is explored, and the optimal screening strategy of colorectal cancer for the Chinese established initially.
  2. Resection section: During the polypectomy, for all pathologically confirmed or NBI-predicted adenomas with size<10mm, 1-2 biopsies were randomly performed on the edge after resection to determine the completion rate of the polypectomy.
  3. Identification and classification section: For Patients regardless of cancer screening or polypectomy, if there is polyp, observation of narrow band imaging (NBI) with or without magnification is required, with 4 white light and NBI images collected and reserved, respectively. If there is magnifying endoscopy, another 4 endoscopic images of magnification are also required. Endoscopists are invited to predict the pathology of polyps according to the NBI International Colorectal Endoscopic (NICE) classification principle and endoscopic images, and upload the pathological results and endoscopic images within 2-4 week after colonoscopy.

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Study Type : Observational
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Colorectal Polyp Care for Diagnosis, Classification and Resection
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
Screening group
All 20000 patients receive FIT test and colonoscopy, whose age, sex, family history, smoking history, body mass index (BMI), and diabetes history of the patients are collected by researchers through pad, equipped with a specially designed database and app. Using colonoscopy results as the gold standard, the screening value of the APCS score and FIT test for the Chinese population is explored, and the optimal screening strategy of colorectal cancer for the Chinese established initially.
Diagnostic Test: FIT test and colonoscopy
All included patients received FIT test and then colonoscopy, with the risk factors of CRC recorded. The diagnostic performance of predicting model (based on FIT and risk factors) and colonoscopy were compared.

Adenoma resection group
During the polypectomy of 5000 patients, for all pathologically confirmed or NBI-predicted adenomas with size<10mm, 1-2 biopsies were randomly performed on the edge after resection to determine the completion rate of the polypectomy.
Diagnostic Test: Polypectomy and biopsy
All included patients received polypectomy, and then biopsy is performed on the edge of resection for patients with < 10 mm adenoma (confirmed by pathology or predicted by NBI images), with the complete resection rate of polyps being calculated.

Identification and classification group
For 25000 patients regardless of cancer screening or polypectomy, if there is polyp, NBI (magnification) observation is required, with 4 white light and NBI images collected and reserved, respectively. If there is magnifying endoscopy, another 4 endoscopic images of magnification are also required. Endoscopists are invited to predict the pathology of polyps according to the NICE classification principle and endoscopic images, and upload the pathological results and endoscopic images within 2-4 week after colonoscopy.
Diagnostic Test: FIT test and colonoscopy
All included patients received FIT test and then colonoscopy, with the risk factors of CRC recorded. The diagnostic performance of predicting model (based on FIT and risk factors) and colonoscopy were compared.

Diagnostic Test: Polypectomy and biopsy
All included patients received polypectomy, and then biopsy is performed on the edge of resection for patients with < 10 mm adenoma (confirmed by pathology or predicted by NBI images), with the complete resection rate of polyps being calculated.

Diagnostic Test: Classification
Pathology of polyps is classified by endoscopists through NICE principle and the performance of classification between endoscopists and computer is compared.




Primary Outcome Measures :
  1. Detection rate of early colorectal cancers and precancerous lesions in colonoscopy and combination of FIT and APCS [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Complete resection rate of polypectomy [ Time Frame: 24 hours ]
  2. Specificity and sensitivity of endoscopists and artificial intelligence-assisted system in classifying polyps [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who referred to the outpatient and received colonoscopy.
Criteria

Inclusion Criteria:

  1. Age between 18 to 75 years old, the gender is not limited.
  2. 3-4 L polyethylene glycol and foaming agent are used for bowel preparation.
  3. Withdrawal time ≥6mins (excluding the time of biopsy)

Exclusion Criteria:

  1. A history of acute myocardial infarction (within 6 months), severe heart, liver, kidney dysfunction, or mental illness.
  2. Patients taking anticoagulants such as aspirin and warfarin, or who have coagulopathy.
  3. Patients with inflammatory bowel disease and colon polyposis.
  4. History of color procedure (including surgery, polypectomy, EMR, and ESD) in screening section
  5. Diameter of polyp greater than 1cm, lateral developmental lesions (LST), colon cancer, lesions requiring ESD and surgery
  6. Patients participating in other clinical trials now or within 60 days.
  7. Intestinal obstruction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712059


Contacts
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Contact: Li Zhaoshen, MD +86-21-25070552 zhaoshenlismmu@gmail.com
Contact: Bai Yu, MD +86-13564665324 baiyu1998@hotmail.com

Locations
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China
Changhai Hospital, Second Military Medical University Recruiting
Shanghai, China, 200433
Contact: zhaoshen Li, MD    86-21-81873241    zhaoshenlismmu@gmail.com   
Principal Investigator: zhaoshen Li, MD         
Changhai Hospital, Second Military Medical University Recruiting
Shanghai, China, 200433
Contact: bai yu, M.D    86-21-81873241    baiyu1998@hotmail.com   
Contact: zhao shengbing, M.D    86-21-81873241    zhaoshengbing@hotmail.com   
Sponsors and Collaborators
Changhai Hospital

Publications:

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Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept and Digestive Endoscopy Center, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03712059     History of Changes
Other Study ID Numbers: NCPC
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhaoshen Li, Changhai Hospital:
Colorectal cancer sreening
Polypectomy
Artificial intelligence

Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical