Early CancerNCT02952794
Endoscopic Submucosal Dissection (ESD) and Endoscopic Mucosal Band Ligation (EMBL) for Early Cancer
An observational study of Early Cancer, run by Fudan University at 2 sites in China.
Trial summary
To compare the treatment methods of endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Early Cancer
- What is being tested?
- endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2017to Dec 2020
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer
Who may be able to join
- Patients with early neoplasm in the gastrointestinal tract
Who cannot join
- Patients who can not meet the surgery
Trial locations and contacts
2 sites in 1 country.
China2 sites
Endoscopy Center, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Endoscopy Center, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Yun-Shi Zhong, PHD, +8613564623481
About this study
To compare the treatment methods of endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer.
- Conditions
- Early Cancer
- Being tested
- endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer
- Keywords
- endoscopic submucosal dissection (ESD), endoscopic mucosal band ligation (EMBL)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancerProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ESD | endoscopic submucosal dissection (ESD)for early cancer Receives: Procedure: endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer | |
| EMBL | endoscopic mucosal band ligation (EMBL) for early cancer Receives: Procedure: endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952794
- Sponsor's protocol ID
- S2015101
- Status last verified
- Oct 2016
- First submitted
- 22 Jun 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Submucosal Dissection (ESD) and Endoscopic Mucosal Band Ligation (EMBL) for Early Cancer
- ClinicalTrials.gov ID
- NCT02952794
- Acronym / sponsor ID
- S2015101
- Conditions
- Early Cancer
- Keywords
- endoscopic submucosal dissection (ESD), endoscopic mucosal band ligation (EMBL)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Nov 2016 (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.
To compare the treatment methods of endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESD | – | Procedure: endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancerendoscopic submucosal dissection (ESD)for early cancer |
| EMBL | – | Procedure: endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancerendoscopic mucosal band ligation (EMBL) for early cancer |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer
Key inclusion criteria (1 listed)
- Patients with early neoplasm in the gastrointestinal tract
Key exclusion criteria (1 listed)
- Patients who can not meet the surgery
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 submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer | Procedure or surgery | EMBL, ESD |
Primary outcome
5-year overall survival
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Cancer, run by Fudan University at 2 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 1 inclusion and 1 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
5-year overall survival (time frame: 5 year). 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 2 Nov 2016.