Colorectal LesionsNCT06399120
Diagnostic Performance of Endocytoscopy for Colorectal Lesions
An observational study of Colorectal Lesions, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer-related death. About 70% of colorectal cancers develop through the adenoma-cancer pathway. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Lesions
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators analyzed only endoscopically or surgically resected colorectal lesions that had been observed and diagnosed with endoscopic methods by endoscopists that were ultimately performed histopathologic examination.
Who may be able to join
- colorectal lesions
Who cannot join
- non-epithelial tumors
- a history of inflammatory bowel disease
- lesions without clear EC images
- specific pathological types
- familial adenomatous polyposis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mingqing Liu
Changchun, Jilin, 130021
Mingqing Liu, +8613204300453, liumq23@mails.jlu.edu.cn
About this study
Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer-related death. About 70% of colorectal cancers develop through the adenoma-cancer pathway. Early detection and resection of colorectal neoplastic lesions significantly reduce the morbidity and mortality of colorectal cancers. Colonoscopy is considered to be the preferred method for screening for colorectal lesions. However, as the number of endoscopic resection increases, the costs associated with pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, it will be very important and urgent to correctly judge the nature of colorectal lesions to avoid pathological diagnosis and then realize optical biopsy. Therefore, to clarify the endoscopic diagnosis of colorectal lesions, many endoscopic techniques have been applied clinically. Such as narrow-band imaging, magnifying narrow-band imaging endoscopy, magnifying chromoendoscopy and endocytoscopy. Endocytoscopy has two modes, EC-NBI mode and EC-staining mode. EC-NBI mode is to observe the microvessel on the mucosal surface of colorectal mucosa after switching the endoscopy to NBI mode. EC-V pattern is used to observe microvessels and then endoscopic diagnosis is performed. The EC-staining mode was that the cell nuclei and glandular duct morphology of colorectal lesions could be observed by endocytoscopy after chemical staining. Endocytoscopic diagnosis is performed clinically after observation of glandular ducts and nuclei. However, current studies on the diagnostic value of endoscopy in colorectal lesions are all retrospective studies with small samples, and there is a lack of clinical studies based on chinese population. Therefore, our center intends to conduct a study of a large sample to explore the diagnostic value of endoscopy in colorectal lesions.
- Conditions
- Colorectal Lesions
- Keywords
- endocytoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of diagnosing colorectal lesions using endocytoscopy
The percentage of patients with a specific type of colorectal disease who received a positive result by endocytoscopy.
Measured: May 2025
specificity of diagnosing colorectal lesions using endocytoscopy
The percentage of patients with non-specific types of colorectal disease who received a negative result using endocytoscopy.
Measured: May 2025
accuracy of diagnosing colorectal lesions using endocytoscopy
The percentage of correct results that is obtained by endocytoscopy.
Measured: May 2025
positive predictive value of diagnosing colorectal lesions using endocytoscopy
The percentage of patients with positive results when using endocytoscopy to diagnose colorectal lesions.
Measured: May 2025
negative predictive value of diagnosing colorectal lesions using endocytoscopy
The percentage of non-patients with negative results when using endocytoscopy to diagnose colorectal lesions.
Measured: May 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 May 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal LesionsStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Xu, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399120
- Sponsor's protocol ID
- 24K102-001
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Endocytoscopy for Colorectal Lesions
- ClinicalTrials.gov ID
- NCT06399120
- Acronym / sponsor ID
- 24K102-001
- Conditions
- Colorectal Lesions
- Keywords
- endocytoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 3 May 2024 (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.
Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer-related death. About 70% of colorectal cancers develop through the adenoma-cancer pathway. Early detection and resection of colorectal neoplastic lesions significantly reduce the morbidity and mortality of colorectal cancers. Colonoscopy is considered to be the preferred method for screening for colorectal lesions. However, as the number of endoscopic resection increases, the costs associated with pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, it will be very important and urgent to correctly judge the nature of colorectal lesions to avoid pathological diagnosis and then realize optical biopsy. Therefore, to clarify the endoscopic diagnosis of colorectal lesions, many endoscopic techniques have been applied clinically. Such as narrow-band imaging, magnifying narrow-band imaging endoscopy, magnifying chromoendoscopy and endocytoscopy. Endocytoscopy has two modes, EC-NBI mode and EC-staining mode. EC-NBI mode is to observe the microvessel on the mucosal surface of colorectal mucosa after switching the endoscopy to NBI mode. EC-V pattern is used to observe microvessels and then endoscopic diagnosis is performed. The EC-staining mode was that the cell nuclei and glandular duct morphology of colorectal lesions could be observed by endocytoscopy after chemical staining. Endocytoscopic diagnosis is performed clinically after observation of glandular ducts and nuclei. However, current studies on the diagnostic value of endoscopy in colorectal lesions are all retrospective studies with small samples, and there is a lack of clinical studies based on chinese population. Therefore, our center intends to conduct a study of a large sample to explore the diagnostic value of endoscopy in colorectal lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators analyzed only endoscopically or surgically resected colorectal lesions that had been observed and diagnosed with endoscopic methods by endoscopists that were ultimately performed histopathologic examination.
Key inclusion criteria (1 listed)
- colorectal lesions
Key exclusion criteria (5 listed)
- non-epithelial tumors
- a history of inflammatory bowel disease
- lesions without clear EC images
- specific pathological types
- familial adenomatous polyposis
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
sensitivity of diagnosing colorectal lesions using endocytoscopy
Time frame: May 2025
The percentage of patients with a specific type of colorectal disease who received a positive result by endocytoscopy.
specificity of diagnosing colorectal lesions using endocytoscopy
Time frame: May 2025
The percentage of patients with non-specific types of colorectal disease who received a negative result using endocytoscopy.
accuracy of diagnosing colorectal lesions using endocytoscopy
Time frame: May 2025
The percentage of correct results that is obtained by endocytoscopy.
positive predictive value of diagnosing colorectal lesions using endocytoscopy
Time frame: May 2025
The percentage of patients with positive results when using endocytoscopy to diagnose colorectal lesions.
negative predictive value of diagnosing colorectal lesions using endocytoscopy
Time frame: May 2025
The percentage of non-patients with negative results when using endocytoscopy to diagnose colorectal lesions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Lesions, run by The First Hospital of Jilin University at 1 site 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 5 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 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Mingqing Liu, Doctor (+8613204300453, liumq23@mails.jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of diagnosing colorectal lesions using endocytoscopy (time frame: May 2025). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2024.