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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

Tracking Information
First Submitted Date October 17, 2018
First Posted Date October 19, 2018
Last Update Posted Date October 25, 2018
Estimated Study Start Date November 1, 2018
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2018)
Detection rate of early colorectal cancers and precancerous lesions in colonoscopy and combination of FIT and APCS [ Time Frame: 24 hours ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03712059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 23, 2018)
  • Complete resection rate of polypectomy [ Time Frame: 24 hours ]
  • Specificity and sensitivity of endoscopists and artificial intelligence-assisted system in classifying polyps [ Time Frame: 24 hours ]
Original Secondary Outcome Measures
 (submitted: October 18, 2018)
  • Complete resection rate of polypectomy [ Time Frame: 24 hours ]
  • Specificity and sensitivity of endoscopists and computer in classifying polyps [ Time Frame: 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title National Colorectal Polyp Care
Official Title National Colorectal Polyp Care for Diagnosis, Classification and Resection
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who referred to the outpatient and received colonoscopy.
Condition Colorectal Polyp
Intervention
  • 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.
Study Groups/Cohorts
  • 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.
    Intervention: Diagnostic Test: FIT test and colonoscopy
  • 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.
    Intervention: Diagnostic Test: Polypectomy and biopsy
  • 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.
    Interventions:
    • Diagnostic Test: FIT test and colonoscopy
    • Diagnostic Test: Polypectomy and biopsy
    • Diagnostic Test: Classification
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 18, 2018)
25000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2019
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Li Zhaoshen, MD +86-21-25070552 zhaoshenlismmu@gmail.com
Contact: Bai Yu, MD +86-13564665324 baiyu1998@hotmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03712059
Other Study ID Numbers NCPC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Zhaoshen Li, Changhai Hospital
Study Sponsor Changhai Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Changhai Hospital
Verification Date October 2018