Gastric TumorNCT01832246
Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion for Early Gastric Cancer
An observational study of Gastric Tumor and Early Gastric Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The accurate prediction of depth of tumor invasion in early gastric cancer is essential for the proper selection of candidates for endoscopic resection. Conventional endoscopy and endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early gastric cancer. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Tumor, Early Gastric Cancer
- How many people
- 560 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with early gastric adenocarcinoma is prospectively enrolled at Seoul National University Hospital.
Who may be able to join
- Patients with early gastric adenocarcinoma undergo both endoscopic staging and endoscopic ultrasonographic staging for depth of invasion
Who cannot join
- patients had previously received neoadjuvant chemotherapy or chemoradiotherapy
- patients with obviously advanced gastric cancer by endoscopy
- the evidence of distant metastasis or extensive adjacent organ invasion on abdominal CT scan
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital
Seoul, Seoul, 110-744
Jeongmin Choi, M.D., 82-2-2072-7209, doct00@hanmail.net
About this study
Official title: Prospective Study of Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion and Endoscopic Tumor Size Estimation for Early Gastric Cancer
The accurate prediction of depth of tumor invasion in early gastric cancer is essential for the proper selection of candidates for endoscopic resection. Conventional endoscopy and endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early gastric cancer. However, there has been no prospective comparative study on the accuracy between the 2 methods. Therefore, the investigators prospectively compare the accuracy between the 2 methods regarding prediction of depth of invasion.
- Conditions
- Gastric Tumor, Early Gastric Cancer
- Keywords
- endoscopy, endosonography, stomach cancer, tumor staging
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging
Measured: up to 2.5 years (end of study, December 2014)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric TumorStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeongmin Choi, Seoul National University Hospital
- Investigators
- Sang Gyun Kim, M.D., Study director, Department of Internal Medicine and Liver Research Institute, Seoul National University College of MedicineJeongmin Choi, M.D., Principal investigator, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832246
- Sponsor's protocol ID
- 20122012
- Status last verified
- Nov 2014
- First submitted
- 4 Jul 2012
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion and Endoscopic Tumor Size Estimation for Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT01832246
- Acronym / sponsor ID
- 20122012
- Conditions
- Gastric Tumor, Early Gastric Cancer
- Keywords
- endoscopy, endosonography, stomach cancer, tumor staging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 16 Apr 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 accurate prediction of depth of tumor invasion in early gastric cancer is essential for the proper selection of candidates for endoscopic resection. Conventional endoscopy and endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early gastric cancer. However, there has been no prospective comparative study on the accuracy between the 2 methods. Therefore, the investigators prospectively compare the accuracy between the 2 methods regarding prediction of depth of invasion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with early gastric adenocarcinoma is prospectively enrolled at Seoul National University Hospital.
Key inclusion criteria (1 listed)
- Patients with early gastric adenocarcinoma undergo both endoscopic staging and endoscopic ultrasonographic staging for depth of invasion
Key exclusion criteria (3 listed)
- patients had previously received neoadjuvant chemotherapy or chemoradiotherapy
- patients with obviously advanced gastric cancer by endoscopy
- the evidence of distant metastasis or extensive adjacent organ invasion on abdominal CT scan
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
diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging
Time frame: up to 2.5 years (end of study, December 2014)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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.
Sang Gyun Kim, M.D. study director
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
Jeongmin Choi, M.D. principal investigator
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
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 Gastric Tumor and Early Gastric Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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 18 Nov 2014. 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 South Korea. 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 Jeongmin Choi, M.D. (82-2-2072-7209, doct00@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging (time frame: up to 2.5 years (end of study, December 2014)). 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 18 Nov 2014.