Trial record 8 of 381 for:    Open Studies | "Stomach Neoplasms"

Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion for Early Gastric Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jeongmin Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01832246
First received: July 4, 2012
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition
Gastric Tumor
Early Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging [ Time Frame: up to 2.5 years (end of study, December 2014) ] [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with early gastric adenocarcinoma is prospectively enrolled at Seoul National University Hospital.

Criteria

Inclusion Criteria:

  • Patients with early gastric adenocarcinoma undergo both endoscopic staging and endoscopic ultrasonographic staging for depth of invasion

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832246

Contacts
Contact: Jeongmin Choi, M.D. 82-2-2072-7209 doct00@hanmail.net

Locations
Korea, Republic of
Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jeongmin Choi, M.D.    82-2-2072-7209    doct00@hanmail.net   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Sang Gyun Kim, M.D. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
Principal Investigator: Jeongmin Choi, M.D. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Jeongmin Choi, professor, Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01832246     History of Changes
Other Study ID Numbers: 20122012
Study First Received: July 4, 2012
Last Updated: April 15, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
endoscopy
endosonography
stomach cancer
tumor staging

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 22, 2014