Mild Dysplasia of EsophagusNCT04170257
Performance of White Light, NBI and Iodine Staining Endoscopy in the Diagnosis of Esophageal Lesions
A study testing Endoscopic examination using white light, NBI and iodine staining in people with Mild Dysplasia of Esophagus and Moderate Dysplasia of Esophagus, run by Peking University Cancer Hospital & Institute at 5 sites in China.
Trial summary
The investigators aim to evaluate the performance of Narrow Band Imaging (NBI) endoscopy in Esophageal Squamous Cell Carcinoma (ESCC) screening, as compared to the currently used White Light Endoscopy (WLE) and Lugol's Iodine Staining Endoscopy (ISE). Read more about this study
- Who is it for?
- Ages 45 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Dysplasia of Esophagus, Moderate Dysplasia of Esophagus, Severe Dysplasia of Esophagus
- What is being tested?
- Endoscopic examination using white light, NBI and iodine staining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 5 sitesChina
- Study dates
- 18 Oct 2019to 31 Dec 2022
- 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 45 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients seek for endoscopic examinations at the endoscopy center in any of the five hospitals included in this study
- Aged 45-69 years
- Have entire esophagus
- Provide written informed consent and leave personal identification and contact information
Who cannot join
- Have contraindications to endoscopic examination (Including but not limited to severe arrhythmia, myocardial infarction, heart failure, hemiplegia, asthma, severe hypertension (≥ 180 / 110mmHg), psychosis, etc )
- Have a history of drug allergy
- Have a history of upper gastrointestinal surgery
- Have a history of radiotherapy or chemotherapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Anyang Cancer Hospital
Anyang, Henan, 455000
Anxiang Liu, MD
- Recruiting
People's Hospital of Hua County, Henan Province
Anyang, Henan, 456400
Yujie He, MD
- Not yet recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Fandong Meng, MD
- Not yet recruiting
Shantou University Medical College Affiliated Cancer Hospital
Shantou, Guangdong
Yi Guo, MD
- Not yet recruiting
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia
Shengjuan Hu, MD
About this study
Official title: Performance of White Light, Narrow Band Imaging and Iodine Staining Endoscopy in the Diagnosis of Esophageal Squamous Epithelium Lesions: A Multicenter Clinical Study in China
The investigators aim to evaluate the performance of Narrow Band Imaging (NBI) endoscopy in Esophageal Squamous Cell Carcinoma (ESCC) screening, as compared to the currently used White Light Endoscopy (WLE) and Lugol's Iodine Staining Endoscopy (ISE). NBI is a simple, safe and non-invasive technique, which can provide real-time optical staining for suspicious lesions. This trial is designated to enroll 10000 participants from five centers located in different regions (North, West and South) in China, which would provide real-world evidence for the recommendation of endoscopic diagnostic technique used in ESCC screening projects.
- Conditions
- Mild Dysplasia of Esophagus, Moderate Dysplasia of Esophagus, Severe Dysplasia of Esophagus, Carcinoma in Situ of Esophagus, Esophageal Squamous Cell Carcinoma
- Being tested
- Endoscopic examination using white light, NBI and iodine staining
- Keywords
- Esophageal Squamous Cell Carcinoma, Population-level screening, Narrow Band Imaging, Iodine Staining, Sensitivity and Specificity
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic examination using white light, NBI and iodine stainingDiagnostic test
Participants' esophagus will be examined by three commonly used diagnostic techniques in the order of : 1. White light endoscopy (WLE); 2. Narrow Band Imaging (NBI) and 3. Iodine Staining Endoscopy (ISE) with 1.2% Lugol's iodine solution. The required observation time is no less than 1 minute for WLE and 2 minutes for NBI and ISE. Endoscopic images of each participant are routinely captured at every 5 centimeters in the esophagus, and information is recorded in detail for each focal lesion. Biopsies are taken from all visually abnormal areas found by any one of the three techniques, histopathologic diagnoses are rendered by two pathologists according to standard criteria and discrepancies are adjudicated by consultation. The recorded endoscopic images for each biopsied lesion are read by two trained researchers and the visualized feature of lesions are decomposed into several indicators (e.g. size, shape, color, and border of lesions) .
| Study group | Role | What they receive |
|---|---|---|
| Opportunistic screening cohort | Experimental | This opportunistic screening cohort is constructed among patients aged 45-69 years who undergo endoscopic examinations at the endoscopy center in any of the five hospitals included in this study. Enrolled participants are requested to complete a computer aided one-on-one questionnaire regarding demographic factors, smoking and alcohol drinking status, dietary habits，digestive tract symptoms and family history of ESCC. Then experienced endoscopists will perform the upper gastrointestinal endoscopic examination for each participant, and the entire esophagus will be visually examined with the white light, NBI and iodine staining endoscopic examination. Receives: Diagnostic Test: Endoscopic examination using white light, NBI and iodine staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Sensitivity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Measured: 0 days
Specificity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Specificity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Measured: 0 days
Positive predictive value (PPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
PPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Measured: 0 days
Negative predictive value (NPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
NPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Measured: 0 days
Secondary outcomes (2)
Weight of each visualized abnormal feature of lesions
The estimated odds ratio of each decomposed graphic abnormal features of lesions, taking "severe dysplasia and above" diagnosed via histopathological analysis as the outcome events.
Measured: 0 days
Discrimination of visualized abnormal features
The area under the curve (AUC) of visualized graphic abnormal features for predicting severe dysplasia and above lesions.
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start18 Oct 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Dysplasia of EsophagusStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Ke, Peking University Cancer Hospital & Institute
- Investigators
- Mengfei Liu, PhD, Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170257
- Sponsor's protocol ID
- 2018KT111
- Status last verified
- Nov 2019
- First submitted
- 17 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of White Light, Narrow Band Imaging and Iodine Staining Endoscopy in the Diagnosis of Esophageal Squamous Epithelium Lesions: A Multicenter Clinical Study in China
- ClinicalTrials.gov ID
- NCT04170257
- Acronym / sponsor ID
- 2018KT111
- Conditions
- Mild Dysplasia of Esophagus, Moderate Dysplasia of Esophagus, Severe Dysplasia of Esophagus, Carcinoma in Situ of Esophagus, Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Squamous Cell Carcinoma, Population-level screening, Narrow Band Imaging, Iodine Staining, Sensitivity and Specificity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Nov 2019 (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.
The investigators aim to evaluate the performance of Narrow Band Imaging (NBI) endoscopy in Esophageal Squamous Cell Carcinoma (ESCC) screening, as compared to the currently used White Light Endoscopy (WLE) and Lugol's Iodine Staining Endoscopy (ISE). NBI is a simple, safe and non-invasive technique, which can provide real-time optical staining for suspicious lesions. This trial is designated to enroll 10000 participants from five centers located in different regions (North, West and South) in China, which would provide real-world evidence for the recommendation of endoscopic diagnostic technique used in ESCC screening projects.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opportunistic screening cohort | Experimental | Diagnostic Test: Endoscopic examination using white light, NBI and iodine stainingThis opportunistic screening cohort is constructed among patients aged 45-69 years who undergo endoscopic examinations at the endoscopy center in any of the five hospitals included in this study. Enrolled participants are requested to complete a computer aided one-on-one questionnaire regarding demographic factors, smoking and alcohol drinking status, dietary habits，digestive tract symptoms and family history of ESCC. Then experienced endoscopists will perform the upper gastrointestinal endoscopic examination for each participant, and the entire esophagus will be visually examined with the white light, NBI and iodine staining endoscopic examination. |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients seek for endoscopic examinations at the endoscopy center in any of the five hospitals included in this study
- Aged 45-69 years
- Have entire esophagus
- Provide written informed consent and leave personal identification and contact information
Key exclusion criteria (4 listed)
- Have contraindications to endoscopic examination (Including but not limited to severe arrhythmia, myocardial infarction, heart failure, hemiplegia, asthma, severe hypertension (≥ 180 / 110mmHg), psychosis, etc )
- Have a history of drug allergy
- Have a history of upper gastrointestinal surgery
- Have a history of radiotherapy or chemotherapy
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 |
|---|---|---|
| Endoscopic examination using white light, NBI and iodine stainingParticipants' esophagus will be examined by three commonly used diagnostic techniques in the order of : 1. White light endoscopy (WLE); 2. Narrow Band Imaging (NBI) and 3. Iodine Staining Endoscopy (ISE) with 1.2% Lugol's iodine solution. The required observation time is no less than 1 minute for WLE and 2 minutes for NBI and ISE. Endoscopic images of each participant are routinely captured at every 5 centimeters in the esophagus, and information is recorded in detail for each focal lesion. Biopsies are taken from all visually abnormal areas found by any one of the three techniques, histopathologic diagnoses are rendered by two pathologists according to standard criteria and discrepancies are adjudicated by consultation. The recorded endoscopic images for each biopsied lesion are read by two trained researchers and the visualized feature of lesions are decomposed into several indicators (e.g. size, shape, color, and border of lesions) . | Diagnostic test | Opportunistic screening cohort |
Primary outcome
Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Time frame: 0 days
Sensitivity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Specificity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Time frame: 0 days
Specificity of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Positive predictive value (PPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Time frame: 0 days
PPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
Negative predictive value (NPV) of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus
Time frame: 0 days
NPV of WLE, NBI and ISE, taking results from histopathological analysis of the biopsy specimens as the golden standard.
2 secondary outcomes
Weight of each visualized abnormal feature of lesions
Time frame: 0 days
Discrimination of visualized abnormal features
Time frame: 0 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
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.
Mengfei Liu, PhD study director
Peking University Cancer Hospital & Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic examination using white light, NBI and iodine staining in people with Mild Dysplasia of Esophagus and Moderate Dysplasia of Esophagus, run by Peking University Cancer Hospital & Institute at 5 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 4 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Yang Ke, MD (86-10-88196762, keyang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of WLE, NBI and ISE in the diagnosis of mild, moderate, severe dysplasia and above lesions in esophagus (time frame: 0 days). 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 20 Nov 2019.