Optical Enhancement EndoscopyNCT03700398
Early Detection of Head and Neck Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma
A study testing first OE and first WLI in people with Optical Enhancement Endoscopy, run by Shandong University at 1 site in China.
Trial summary
the investigators randomly divide the eligible objects into two groups:1. objects in this group will first receive OE endoscopy observation and subsequent white light imaging(WLI) observation during oropharynx and hypopharynx; 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optical Enhancement Endoscopy
- What is being tested?
- first OE and first WLI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 1 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- order than 18 years old
- Previous or current histopathological pathology confirmed the presence of esophageal squamous cell carcinoma
Who cannot join
- Previously confirmed pharynx/oropharyngeal squamous cell carcinoma
- Advanced pharynx/hypopharyngeal squamous cell carcinoma
- Pregnant women and lactating women
- pharyngeal or esophageal stenosis, esophageal varices, or active digestive tract hemorrhage influence the observation or fail to obtain pathological diagnosis
- Previous chemotherapy or radiation therapy affected observation
- Not completed gastroscopy or refused to take biopsy for various reasons
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- Mental illnesses such as anxiety and depression affect the endoscopic observation
- Severe systemic disease, can not tolerate gastroscopy
- Refusal to sign informed consent books
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Yanqing Li, PHD, 86-531-82169236, liyanqing@sdu.edu.cn
About this study
Official title: Early Detection of Oropharyngeal and Hypopharyngeal Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma by White Light Imaging and Optical Enhancement(OE)
the investigators randomly divide the eligible objects into two groups:1. objects in this group will first receive OE endoscopy observation and subsequent white light imaging(WLI) observation during oropharynx and hypopharynx; 2. objects in this group will first receive WLI observation and subsequent OE observation during oropharynx and hypopharynx. Then, the investigators will compare the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma of two groups to find if OE endoscopy can improve the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma in esophageal cancer patients.
- Conditions
- Optical Enhancement Endoscopy
- Being tested
- first OE, first WLI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first OEDevice
optical enhancement(OE)，a kind of electron straining endoscopy
first WLIDevice
the routine in the clinical practice
| Study group | Role | What they receive |
|---|---|---|
| first OE | Experimental | Not described Receives: Device: first OE |
| First WLI | Other | Not described Receives: Device: first WLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
detect rate
the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Oct 2017
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Enhancement EndoscopyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700398
- Sponsor's protocol ID
- 2017SDU-QILU-06
- Status last verified
- Oct 2018
- First submitted
- 23 Sep 2018
- Last updated
- 9 Oct 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 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Oropharyngeal and Hypopharyngeal Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma by White Light Imaging and Optical Enhancement(OE)
- ClinicalTrials.gov ID
- NCT03700398
- Acronym / sponsor ID
- 2017SDU-QILU-06
- Conditions
- Optical Enhancement Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 9 Oct 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.
the investigators randomly divide the eligible objects into two groups:1. objects in this group will first receive OE endoscopy observation and subsequent white light imaging(WLI) observation during oropharynx and hypopharynx; 2. objects in this group will first receive WLI observation and subsequent OE observation during oropharynx and hypopharynx. Then, the investigators will compare the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma of two groups to find if OE endoscopy can improve the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma in esophageal cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first OE | Experimental | Device: first OE |
| First WLI | Other | Device: first WLI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- order than 18 years old
- Previous or current histopathological pathology confirmed the presence of esophageal squamous cell carcinoma
Key exclusion criteria (9 listed)
- Previously confirmed pharynx/oropharyngeal squamous cell carcinoma
- Advanced pharynx/hypopharyngeal squamous cell carcinoma
- Pregnant women and lactating women
- pharyngeal or esophageal stenosis, esophageal varices, or active digestive tract hemorrhage influence the observation or fail to obtain pathological diagnosis
- Previous chemotherapy or radiation therapy affected observation
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 |
|---|---|---|
| first OEoptical enhancement(OE)，a kind of electron straining endoscopy | Device | first OE |
| first WLIthe routine in the clinical practice | Device | First WLI |
Primary outcome
detect rate
Time frame: 12 months
the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing first OE and first WLI in people with Optical Enhancement Endoscopy, 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 9 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 9 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect rate (time frame: 12 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 9 Oct 2018.