Esophageal Squamous Intraepithelial NeoplasiaNCT01909518
Detection of Early Esophageal Squamous Neoplasia
An observational study of Esophageal Squamous Intraepithelial Neoplasia, run by Shandong University at 1 site in China.
Trial summary
The aim of the present study： 1. To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia. 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Esophageal Squamous Intraepithelial Neoplasia
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Dec 2013
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study
Who may be able to join
- Patients aged between 50 and 80 years old
- Patients undergo screening endoscopy or histologically verified esophageal squamous intraepithelial neoplasia before.
Who cannot join
- Advanced esophageal, gastric or duodenal cancer
- History of upper GI tract surgery
- Coagulopathy or acute GI bleeding
- Pregnant or breast-feeding (for females)
- Impaired renal function
- Allergy to fluorescein sodium
- 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, MD. PhD., 86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn
About this study
Official title: Detection of Early Esophageal Squamous Neoplasia by Using Virtual Chromoendoscopy and Probe-based Confocal Laser Endomicroscopy
The aim of the present study：
- To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.
- To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy
Read the detailed description
Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device and has shown its value for diagnosing Barrett's esophagus, colonal polyps and etc. However, none research has focus on early esophageal squamous neoplasia until now. Previous diagnosis of early esophageal neoplasia is based on the lugol staining which is time wasting and have many adverse events.Other researches have suggested virtual chromoendoscopys are beneficial for screening esophageal tumors. Therefore, the aim of the present study is 1.To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia according to the surface maturation scoring(SMS) diagnostic criteria and 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy(I-SCAN).
- Keywords
- Esophageal Squamous Intraepithelial Neoplasia, surface maturation scoring, probe-based confocal laser endomicroscopy, virtual chromoendoscopy
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 |
|---|---|---|
| pCLE examination | pCLE is used to distinguish the suspected lesions detected by I-SCAN in esophagus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of pCLE on early esophageal squamous neoplasia
Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of early esophageal squamous neoplasia by using probe-based confocal laser endomicroscopy
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Intraepithelial NeoplasiaStudies 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
- Retrospective
- Enrolment
- 200 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, MD. PhD., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909518
- Sponsor's protocol ID
- 2013SDU-QILU-G02
- Status last verified
- Jul 2013
- First submitted
- 24 Jul 2013
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Early Esophageal Squamous Neoplasia by Using Virtual Chromoendoscopy and Probe-based Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT01909518
- Acronym / sponsor ID
- 2013SDU-QILU-G02
- Keywords
- Esophageal Squamous Intraepithelial Neoplasia, surface maturation scoring, probe-based confocal laser endomicroscopy, virtual chromoendoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Jul 2013 (estimated)
- 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 aim of the present study：
- To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.
- To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy
Detailed description
Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device and has shown its value for diagnosing Barrett's esophagus, colonal polyps and etc. However, none research has focus on early esophageal squamous neoplasia until now. Previous diagnosis of early esophageal neoplasia is based on the lugol staining which is time wasting and have many adverse events.Other researches have suggested virtual chromoendoscopys are beneficial for screening esophageal tumors. Therefore, the aim of the present study is 1.To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia according to the surface maturation scoring(SMS) diagnostic criteria and 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy(I-SCAN).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pCLE examination | – | –pCLE is used to distinguish the suspected lesions detected by I-SCAN in esophagus |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study
Key inclusion criteria (2 listed)
- Patients aged between 50 and 80 years old
- Patients undergo screening endoscopy or histologically verified esophageal squamous intraepithelial neoplasia before.
Key exclusion criteria (7 listed)
- Advanced esophageal, gastric or duodenal cancer
- History of upper GI tract surgery
- Coagulopathy or acute GI bleeding
- Pregnant or breast-feeding (for females)
- Impaired renal function
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 diagnostic accuracy of pCLE on early esophageal squamous neoplasia
Time frame: 6 month
Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of early esophageal squamous neoplasia by using probe-based confocal laser endomicroscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
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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, MD. PhD. principal investigator
Qilu Hospital of 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 Esophageal Squamous Intraepithelial Neoplasia, 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 2 inclusion and 7 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 26 Jul 2013. 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 Yangqing Li, PhD. MD (86-531-82169236 ext. 82169508, 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 diagnostic accuracy of pCLE on early esophageal squamous neoplasia (time frame: 6 month). 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 26 Jul 2013.