Low Grade Intraepithelial NeoplasiaNCT06389448
Comparison of pCLE and EB in Gastric Lesion Diagnosis
A study testing pCLE-gastr in people with Low Grade Intraepithelial Neoplasia and High Grade Intraepithelial Neoplasia, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Grade Intraepithelial Neoplasia, High Grade Intraepithelial Neoplasia, Early Gastric Cancer
- What is being tested?
- pCLE-gastr
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2024to Oct 2026
- Phase
- Interventional
- 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
Who may be able to join
- Over 18 years old and under 75 years old;
- Patients with pathological diagnosis of LGIN, HGIN or early gastric cancer after conventional endoscopy biopsy, whose lesion has clear boundaries under endoscopic observation and is to be admitted for ESD surgery;
- Patients who meet the indications for endoscopic resection of early gastric cancer, or LGIN patients who intend to undergo ESD surgery;
- Patients who are able to provide pathological specimens/sections of previous endoscopic biopsy (in principle, it should be a case of this center).
Who cannot join
- Patients with advanced gastric cancer or previous gastrectomy;
- Patients with severe cardiopulmonary dysfunction, liver cirrhosis, renal dysfunction, acute gastrointestinal bleeding, esophageal-gastro varices, and coagulation disorders;
- Patients who have a positive result in the fluorescein sodium allergy test;
- Pregnant and lactating women;
- Patients who have psychiatric disorders and are unable to cooperate with endoscopy or sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Bin Cheng, Professor, 86-027-8366-3333, b.cheng@tjh.tjmu.edu.cn
Yilin Gu, 86-19884836004, yilingu2019@163.com
About this study
Official title: Comparison of Probe-based Confocal Laser Endomicroscopy and Traditional Endoscopic Biopsies in the Diagnosis of Gastric Cancer and Precancerous Lesions: a Prospective Multicenter Comparative Study
This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research.
Read the detailed description
Traditional endoscopic biopsies can only obtain limited tissues from the whole lesion and is invasive, while probe-based confocal laser endomicroscopy (pCLE) can obtain images at a cellular level of the entire lesion area in real time and non-invasively. There were only single-center and small-sample previous researches for comparing the diagnostic accuracy of CLE and traditional biopsy in the entire gastric lesions, and they did not distinguish gastric low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN). Thus, this study aims to further verify whether pCLE or pCLE combined with biopsy can improve the diagnostic accuracy of the overall lesion and reduce the histological upstaging rate of gastric LGIN after endoscopic submucosal dissection (ESD) by using large sample data and a new pCLE classification method, so as to achieve better guidance of clinical treatment. While verifying the diagnostic efficacy of pCLE, the data of the participants will be collected and collated, and an endoscopic image database will be constructed for the follow-up research.
- Conditions
- Low Grade Intraepithelial Neoplasia, High Grade Intraepithelial Neoplasia, Early Gastric Cancer, Gastric Intraepithelial Neoplasia
- Being tested
- pCLE-gastr
- Keywords
- confocal laser endomicroscopy, endoscopic biopsy, Intraepithelial Neoplasia, gastric cancer
- Medical subject headings
- Stomach Neoplasms, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pCLE-gastrDevice
After identifying the location of the lesion through white light endoscopy, the pCLE operation is performed to acquire images from the specific gastric lesions, and finally the ESD routine is performed.
| Study group | Role | What they receive |
|---|---|---|
| pCLE-gastr | Other | pCLE will be used to acquire the images from the gastric tissue of the participants after preoperative fluorescein sodium allergy test (negative) and pre-ESD assessment，and before ESD resection. Receives: Device: pCLE-gastr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion
Using the pathological diagnostic result as the criteria, the accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be used to evaluate the diagnostic efficacy in diagnosing LGIN, HGIN and early gastric cancer.
Measured: immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months
Secondary outcomes (1)
The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion
Using the pathological diagnostic result as the ending, the histological upstaging rate from endoscopic biopsy or pCLE will be used to evaluate the diagnostic efficacy.
Measured: immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start11 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants undergo pCLE after pre-ESD assessment and before ESD resection.
- Masking
- None (open label)
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Cheng, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389448
- Sponsor's protocol ID
- pCLE vs EB 2024tj
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 7 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Probe-based Confocal Laser Endomicroscopy and Traditional Endoscopic Biopsies in the Diagnosis of Gastric Cancer and Precancerous Lesions: a Prospective Multicenter Comparative Study
- ClinicalTrials.gov ID
- NCT06389448
- Acronym / sponsor ID
- pCLE vs EB 2024tj
- Conditions
- Low Grade Intraepithelial Neoplasia, High Grade Intraepithelial Neoplasia, Early Gastric Cancer, Gastric Intraepithelial Neoplasia
- Keywords
- confocal laser endomicroscopy, endoscopic biopsy, Intraepithelial Neoplasia, gastric cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Apr 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.
This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research.
Detailed description
Traditional endoscopic biopsies can only obtain limited tissues from the whole lesion and is invasive, while probe-based confocal laser endomicroscopy (pCLE) can obtain images at a cellular level of the entire lesion area in real time and non-invasively. There were only single-center and small-sample previous researches for comparing the diagnostic accuracy of CLE and traditional biopsy in the entire gastric lesions, and they did not distinguish gastric low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN). Thus, this study aims to further verify whether pCLE or pCLE combined with biopsy can improve the diagnostic accuracy of the overall lesion and reduce the histological upstaging rate of gastric LGIN after endoscopic submucosal dissection (ESD) by using large sample data and a new pCLE classification method, so as to achieve better guidance of clinical treatment. While verifying the diagnostic efficacy of pCLE, the data of the participants will be collected and collated, and an endoscopic image database will be constructed for the follow-up research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants undergo pCLE after pre-ESD assessment and before ESD resection.
| Arm | Type | Receives |
|---|---|---|
| pCLE-gastr | Other | Device: pCLE-gastrpCLE will be used to acquire the images from the gastric tissue of the participants after preoperative fluorescein sodium allergy test (negative) and pre-ESD assessment，and before ESD resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old and under 75 years old;
- Patients with pathological diagnosis of LGIN, HGIN or early gastric cancer after conventional endoscopy biopsy, whose lesion has clear boundaries under endoscopic observation and is to be admitted for ESD surgery;
- Patients who meet the indications for endoscopic resection of early gastric cancer, or LGIN patients who intend to undergo ESD surgery;
- Patients who are able to provide pathological specimens/sections of previous endoscopic biopsy (in principle, it should be a case of this center).
Key exclusion criteria (5 listed)
- Patients with advanced gastric cancer or previous gastrectomy;
- Patients with severe cardiopulmonary dysfunction, liver cirrhosis, renal dysfunction, acute gastrointestinal bleeding, esophageal-gastro varices, and coagulation disorders;
- Patients who have a positive result in the fluorescein sodium allergy test;
- Pregnant and lactating women;
- Patients who have psychiatric disorders and are unable to cooperate with endoscopy or sign 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pCLE-gastrAfter identifying the location of the lesion through white light endoscopy, the pCLE operation is performed to acquire images from the specific gastric lesions, and finally the ESD routine is performed. | Device | pCLE-gastr |
Primary outcome
Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion
Time frame: immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months
Using the pathological diagnostic result as the criteria, the accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be used to evaluate the diagnostic efficacy in diagnosing LGIN, HGIN and early gastric cancer.
1 secondary outcome
The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion
Time frame: immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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?
A study testing pCLE-gastr in people with Low Grade Intraepithelial Neoplasia and High Grade Intraepithelial Neoplasia, run by Huazhong University of Science and Technology 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 4 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 7 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 Yilin Gu (86-19884836004, yilingu2019@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion (time frame: immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months). 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 7 May 2024.