Colorectal PolypNCT03359343
Computer-assisted Diagnosis System Based on Linked Colour Imaging
An observational study of Colorectal Polyp and Linked Color Imaging, run by Affiliated Hospital to Academy of Military Medical Sciences at 2 sites in China.
Trial summary
Linked color imaging (LCI)，a new endoscopy modality, creates clear and bright images by using short wavelength narrow band laser light. LCI can make red area appear redder and white areas appear whiter. Thus, it may be possible to distinguish adenoma and non-adenoma polyps based on color evaluation of LCI images. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp, Linked Color Imaging, Computer-aided Diagnosis
- How many people
- 250 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2017to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: consecutive patients undergoing colonoscopy
Who may be able to join
- at least one polyp found during colonoscopy examination.
Who cannot join
- poor quality of bowel preparation which impedes histology evaluation; previous resection of colon; inflammatory bowel disease; familiar adenomatous polyposis; Peutz-Jeghers syndrome or other polyposis syndrome.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Recruiting
Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
Yan Liu, Ph.D., 010-66947473, 13911798288@163.com
- Active, not recruiting
Department of Gastroenterology, Affilited Hospital to Academy of Military Medical Sciences
Beijing, 100071
About this study
Official title: Computer-aided Classification of Colorectal Polyp by Using Linked Colour Imaging
Linked color imaging (LCI)，a new endoscopy modality, creates clear and bright images by using short wavelength narrow band laser light. LCI can make red area appear redder and white areas appear whiter. Thus, it may be possible to distinguish adenoma and non-adenoma polyps based on color evaluation of LCI images. This study aimed to assess the correlation between histology results and LCI images. Moreover, the investigators conducted a pilot study to explore the clinical potential of LCI to distinguish adenoma and non-adenoma polyps and the accuracy of an automatic computer-aided diagnosis system using LCI imagine to predict histology polyps when compared to human experts physicians.
Read the detailed description
This study consists of a retrospective analysis and a pilot study. In the retrospective study, the investigators tried to find out an correlation between LCI images and histology results for polyp lesions. And a computer-aided analysis of the images was conducted to demonstrate the correlation objectively. Thereafter,a pilot study was performed to explore whether the previous correlation could be easily learned to distinguish adenoma and non-adenoma polyps by comparing the results of experts diagnosis of LCI image and non-experts. Also, in the pilot study, the investigators assessed the accuracy of an automate histology diagnosis method for polyp LCI images using the computer-aided system when compared to human experts physicians. Throughout the entire research, histology results are regarded as gold standard.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experts | In this group, two experts distinguish a set of polyps on LCI images as adenoma or non-adenoma. | |
| non-experts | In this group, two non-experts distinguish the set of polyps(the same to experts group) on LCI images as adenoma or non-adenoma. | |
| Computer-aided diagnosis system | In this group, a newly developed computer-aided diagnosis system will be used to distinguish a set of polyps as adenoma or non-adenoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LCI accuracy
the accuracy between a novel developed computer-aided diagnosis system and human experts physicians o distinguish adenoma polyps and non-adenoma polyps based on LCI image.
Measured: June 1, 2018
Secondary outcomes (2)
the short learning curve
the accuracy between experts and non-experts to distinguish adenoma polyps and non-adenoma polyps based on LCI image was compared to explore whether LCI method is of an shorter learning curve.
Measured: June 1, 2018
the correlation
the correlation between LCI image and histology results were retrospectively explored
Measured: June 1, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Oct 2017
- Primary completion1 Feb 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, Study director, Department of gastroenterology, Affiliated Hospital to Academy of Military Medical Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359343
- Sponsor's protocol ID
- 307-LCI-CAD
- Status last verified
- Jan 2018
- First submitted
- 27 Nov 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fukuda H, Miura Y, Hayashi Y, Takezawa T, Ino Y, Okada M, Osawa H, Lefor AK, Yamamoto H. Linked color imaging technology facilitates early detection of flat gastric cancers. Clin J Gastroenterol. 2015 Dec;8(6):385-9. doi: 10.1007/s12328-015-0612-9. Epub 2015 Nov 11.
PubMed 26560036Sun X, Dong T, Bi Y, Min M, Shen W, Xu Y, Liu Y. Linked color imaging application for improving the endoscopic diagnosis accuracy: a pilot study. Sci Rep. 2016 Sep 19;6:33473. doi: 10.1038/srep33473.
PubMed 27641243Dohi O, Yagi N, Onozawa Y, Kimura-Tsuchiya R, Majima A, Kitaichi T, Horii Y, Suzuki K, Tomie A, Okayama T, Yoshida N, Kamada K, Katada K, Uchiyama K, Ishikawa T, Takagi T, Handa O, Konishi H, Naito Y, Itoh Y. Linked color imaging improves endoscopic diagnosis of active Helicobacter pylori infection. Endosc Int Open. 2016 Jul;4(7):E800-5. doi: 10.1055/s-0042-109049.
PubMed 27556101
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-aided Classification of Colorectal Polyp by Using Linked Colour Imaging
- ClinicalTrials.gov ID
- NCT03359343
- Acronym / sponsor ID
- 307-LCI-CAD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Feb 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Linked color imaging (LCI)，a new endoscopy modality, creates clear and bright images by using short wavelength narrow band laser light. LCI can make red area appear redder and white areas appear whiter. Thus, it may be possible to distinguish adenoma and non-adenoma polyps based on color evaluation of LCI images. This study aimed to assess the correlation between histology results and LCI images. Moreover, the investigators conducted a pilot study to explore the clinical potential of LCI to distinguish adenoma and non-adenoma polyps and the accuracy of an automatic computer-aided diagnosis system using LCI imagine to predict histology polyps when compared to human experts physicians.
Detailed description
This study consists of a retrospective analysis and a pilot study. In the retrospective study, the investigators tried to find out an correlation between LCI images and histology results for polyp lesions. And a computer-aided analysis of the images was conducted to demonstrate the correlation objectively. Thereafter,a pilot study was performed to explore whether the previous correlation could be easily learned to distinguish adenoma and non-adenoma polyps by comparing the results of experts diagnosis of LCI image and non-experts. Also, in the pilot study, the investigators assessed the accuracy of an automate histology diagnosis method for polyp LCI images using the computer-aided system when compared to human experts physicians. Throughout the entire research, histology results are regarded as gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experts | – | –In this group, two experts distinguish a set of polyps on LCI images as adenoma or non-adenoma. |
| non-experts | – | –In this group, two non-experts distinguish the set of polyps(the same to experts group) on LCI images as adenoma or non-adenoma. |
| Computer-aided diagnosis system | – | –In this group, a newly developed computer-aided diagnosis system will be used to distinguish a set of polyps as adenoma or non-adenoma. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients undergoing colonoscopy
Key inclusion criteria (1 listed)
- at least one polyp found during colonoscopy examination.
Key exclusion criteria (1 listed)
- poor quality of bowel preparation which impedes histology evaluation; previous resection of colon; inflammatory bowel disease; familiar adenomatous polyposis; Peutz-Jeghers syndrome or other polyposis syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LCI accuracy
Time frame: June 1, 2018
the accuracy between a novel developed computer-aided diagnosis system and human experts physicians o distinguish adenoma polyps and non-adenoma polyps based on LCI image.
2 secondary outcomes
the short learning curve
Time frame: June 1, 2018
the correlation
Time frame: June 1, 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Background: PubMed 26560036Fukuda H, Miura Y, Hayashi Y, Takezawa T, Ino Y, Okada M, Osawa H, Lefor AK, Yamamoto H. Linked color imaging technology facilitates early detection of flat gastric cancers. Clin J Gastroenterol. 2015 Dec;8(6):385-9. doi: 10.1007/s12328-015-0612-9. Epub 2015 Nov 11.
- Background: PubMed 27641243Sun X, Dong T, Bi Y, Min M, Shen W, Xu Y, Liu Y. Linked color imaging application for improving the endoscopic diagnosis accuracy: a pilot study. Sci Rep. 2016 Sep 19;6:33473. doi: 10.1038/srep33473.
- Background: PubMed 27556101Dohi O, Yagi N, Onozawa Y, Kimura-Tsuchiya R, Majima A, Kitaichi T, Horii Y, Suzuki K, Tomie A, Okayama T, Yoshida N, Kamada K, Katada K, Uchiyama K, Ishikawa T, Takagi T, Handa O, Konishi H, Naito Y, Itoh Y. Linked color imaging improves endoscopic diagnosis of active Helicobacter pylori infection. Endosc Int Open. 2016 Jul;4(7):E800-5. doi: 10.1055/s-0042-109049.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Liu study director
Department of gastroenterology, Affiliated Hospital to Academy of Military Medical Sciences.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyp and Linked Color Imaging, run by Affiliated Hospital to Academy of Military Medical Sciences at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Min, M.D. (+86-010-66947473, minmin823@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LCI accuracy (time frame: June 1, 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359343, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.