Colorectal PolypsNCT03620695
Confocal Laser Endomicroscopy With Topical Cresyl Violet for Colorectal Polyps
An observational study of Colorectal Polyps, run by Shandong University at 1 site in China.
Trial summary
Probe-based confocal laser endomicroscopy (pCLE) has been shown to a reliable diagnostic method enabling in vivo microscopic imaging during ongoing endoscopy. Usually fluorescein then serves as a contrast agent for pCLE, but it does not allow direct nuclear visualization, must be injected, leads to a transient skin… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Polyps
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to Oct 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients undergoing surveillance or screening colonoscopies will be recruited in this study at Qilu Hospital, Shandong University.
Who may be able to join
- Patients aged from 18 to 75 years, with polyps found during surveillance or screening colonoscopies.
Who cannot join
- Contraindications to CV (such as allergy);
- Pregnancy or breastfeeding;
- Serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function;
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PhD. MD., 18678827666, liyanqing@sdu.edu.cn
About this study
Official title: Probe-based Confocal Laser Endomicroscopy With Topical Cresyl Violet for Diagnosis of Colorectal Polyps
Probe-based confocal laser endomicroscopy (pCLE) has been shown to a reliable diagnostic method enabling in vivo microscopic imaging during ongoing endoscopy. Usually fluorescein then serves as a contrast agent for pCLE, but it does not allow direct nuclear visualization, must be injected, leads to a transient skin discoloration, and may have allergic side effects. This study aimed to establish a single topical dye, cresyl violet (CV) for pCLE imaging, to describe pCLE interpretation criteria for the characterization of colorectal polyps with histopathological correlation, and to perform the validation of these criteria.
- Conditions
- Colorectal Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation
Measured: 5 months
Number of diagnostic agreement between pCLE with topical CV and histopathological results
Measured: 5 months
Number of participants with procedure-related adverse events
Measured: 5 months
Number of pCLE imaging failure with topical CV
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jun 2018
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD. MD., Study director, Department of Gastroenterology, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620695
- Sponsor's protocol ID
- 2018SDU-QILU-03
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probe-based Confocal Laser Endomicroscopy With Topical Cresyl Violet for Diagnosis of Colorectal Polyps
- ClinicalTrials.gov ID
- NCT03620695
- Acronym / sponsor ID
- 2018SDU-QILU-03
- Conditions
- Colorectal Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 8 Aug 2018 (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.
Probe-based confocal laser endomicroscopy (pCLE) has been shown to a reliable diagnostic method enabling in vivo microscopic imaging during ongoing endoscopy. Usually fluorescein then serves as a contrast agent for pCLE, but it does not allow direct nuclear visualization, must be injected, leads to a transient skin discoloration, and may have allergic side effects. This study aimed to establish a single topical dye, cresyl violet (CV) for pCLE imaging, to describe pCLE interpretation criteria for the characterization of colorectal polyps with histopathological correlation, and to perform the validation of these criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients undergoing surveillance or screening colonoscopies will be recruited in this study at Qilu Hospital, Shandong University.
Key inclusion criteria (1 listed)
- Patients aged from 18 to 75 years, with polyps found during surveillance or screening colonoscopies.
Key exclusion criteria (4 listed)
- Contraindications to CV (such as allergy);
- Pregnancy or breastfeeding;
- Serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function;
- Inability to provide informed consent.
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
The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation
Time frame: 5 months
Number of diagnostic agreement between pCLE with topical CV and histopathological results
Time frame: 5 months
Number of participants with procedure-related adverse events
Time frame: 5 months
Number of pCLE imaging failure with topical CV
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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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.
Yanqing Li, PhD. MD. study director
Department of Gastroenterology, Qilu Hospital, Shandong University
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 Polyps, run by Shandong 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 4 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 8 Aug 2018. 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 Yanqing Li, PhD. MD. (18678827666, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pCLE with topical CV interpretation criteria for the characterization of colorectal polyps with histopathological correlation (time frame: 5 months). The study lists 4 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 8 Aug 2018.