Gastric Cancer Registry for Epidemiology and Molecular Risk Factor
Analysis and Prediction of Epidemiology and Molecular Biologic Risks of Gastric Cancer by Multicenter Registry
1 other identifier
observational
9,000
1 country
1
Brief Summary
This study is a multi-center, prospective cohort study which are planned to enroll the 2,500 patients who diagnosed the primary gastric cancer and 5,000 healthy normal cohort participants for 5 years. All participants who enrolled in this registry, the participants were questioned by the gastric cancer survey and the serum and tissue of these participants were analyzed. The main aim of this study is
- 1.To evaluate the optimal interval of endoscopic screening for early detection of gastric cancer and risk factors in Korean.
- 2.To evaluate the diagnostic validity of serum biomarker (combining pepsinogen, H pylori IgG Antibody, and TFF3) as a screening test for detection of GC in Korean.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 5, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMay 19, 2020
May 1, 2020
4.7 years
February 5, 2017
May 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prediction of risk factors for gastric cancer and definition of optimal endoscopic screening interval
Up to 5 years
Secondary Outcomes (9)
The diagnostic validity of serum biomarker (serum pepsinogen and TFF3) for detection of gastric cancer
up to 5 years
Analysis of proportion of each treatment of gastric cancer and 5 year survival
up to 10 years
Analysis of quality of life questionnaire after early gastric cancer between endoscopic treatment group and surgery group
up to 6 years
the incidence of gastric cancer development in control group
up to 20 years
the incidence of metachronous gastric neoplasm after endoscopic treatment or surgery
up to 10 years
- +4 more secondary outcomes
Study Arms (2)
Gastric cancer group
The patients aged more than 18 years who were diagnosed primary gastric adenocarcinoma.
Control group
The participants aged more than 40 years without previous history of gastric cancer.
Eligibility Criteria
This cohort study is designed to enroll the patients who are diagnosed gastric cancer and healthy control participants by multicenter-prospective registry. From now on, we are willing to enroll about 2,500 gastric cancer patients and about 5,000 control group for 5 years.
You may qualify if:
- The patients who were diagnosed of primary gastric adenocarcinoma and drew up agreement for understanding and enrollment of this study.
You may not qualify if:
- Being treated (surgery, endoscopic resection and chemoradiation) after the diagnosis of gastric cancer; metastatic gastric cancer; refusal to participation of this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seong Woo Jeon
Daegu, South Korea
Related Publications (10)
Lim SH, Kwon JW, Kim N, Kim GH, Kang JM, Park MJ, Yim JY, Kim HU, Baik GH, Seo GS, Shin JE, Joo YE, Kim JS, Jung HC. Prevalence and risk factors of Helicobacter pylori infection in Korea: nationwide multicenter study over 13 years. BMC Gastroenterol. 2013 Jun 24;13:104. doi: 10.1186/1471-230X-13-104.
PMID: 23800201RESULTForman D, Newell DG, Fullerton F, Yarnell JW, Stacey AR, Wald N, Sitas F. Association between infection with Helicobacter pylori and risk of gastric cancer: evidence from a prospective investigation. BMJ. 1991 Jun 1;302(6788):1302-5. doi: 10.1136/bmj.302.6788.1302.
PMID: 2059685RESULTParsonnet J, Friedman GD, Vandersteen DP, Chang Y, Vogelman JH, Orentreich N, Sibley RK. Helicobacter pylori infection and the risk of gastric carcinoma. N Engl J Med. 1991 Oct 17;325(16):1127-31. doi: 10.1056/NEJM199110173251603.
PMID: 1891020RESULTHelicobacter and Cancer Collaborative Group. Gastric cancer and Helicobacter pylori: a combined analysis of 12 case control studies nested within prospective cohorts. Gut. 2001 Sep;49(3):347-53. doi: 10.1136/gut.49.3.347.
PMID: 11511555RESULTLee YC, Chiang TH, Chou CK, Tu YK, Liao WC, Wu MS, Graham DY. Association Between Helicobacter pylori Eradication and Gastric Cancer Incidence: A Systematic Review and Meta-analysis. Gastroenterology. 2016 May;150(5):1113-1124.e5. doi: 10.1053/j.gastro.2016.01.028. Epub 2016 Feb 2.
PMID: 26836587RESULTDhillon PK, Farrow DC, Vaughan TL, Chow WH, Risch HA, Gammon MD, Mayne ST, Stanford JL, Schoenberg JB, Ahsan H, Dubrow R, West AB, Rotterdam H, Blot WJ, Fraumeni JF Jr. Family history of cancer and risk of esophageal and gastric cancers in the United States. Int J Cancer. 2001 Jul 1;93(1):148-52. doi: 10.1002/ijc.1294.
PMID: 11391635RESULTMinami Y, Tateno H. Associations between cigarette smoking and the risk of four leading cancers in Miyagi Prefecture, Japan: a multi-site case-control study. Cancer Sci. 2003 Jun;94(6):540-7. doi: 10.1111/j.1349-7006.2003.tb01480.x.
PMID: 14529588RESULTIijima K, Koike T, Abe Y, Ara N, Uno K, Imatani A, Ohara S, Shimosegawa T. Alteration of correlation between serum pepsinogen concentrations and gastric acid secretion after H. pylori eradication. J Gastroenterol. 2009;44(8):819-25. doi: 10.1007/s00535-009-0066-2. Epub 2009 May 14.
PMID: 19440811RESULTNam SY, Jeon SW, Kwon JG, Chung YJ, Kwon YH, Lee SH, Lee JY, Yang CH, Jo J. Association of Soy Foods With Gastric Cancer Considering Helicobacter pylori: A Multi-Center Case-Control Study. J Gastric Cancer. 2024 Oct;24(4):436-450. doi: 10.5230/jgc.2024.24.e39.
PMID: 39375058DERIVEDLee HS, Jeon SW, Nomura S, Seto Y, Kwon YH, Nam SY, Ishibashi Y, Ohtsu H, Ohmoto Y, Yang HM. Screening Biomarker as an Alternative to Endoscopy for the Detection of Early Gastric Cancer: The Combination of Serum Trefoil Factor Family 3 and Pepsinogen. Gastroenterol Res Pract. 2018 May 9;2018:1024074. doi: 10.1155/2018/1024074. eCollection 2018.
PMID: 29977284DERIVED
Biospecimen
Serum: pepsinogen I and II, Helicobacter pylori IgG Antibody, serum TFF3 Gastric mucosal specimen: tumor and normal mucosa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seong Woo Jeon, Professor
Gastric Cancer Center, Kyungpook National University Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 5, 2017
First Posted
February 8, 2017
Study Start
August 1, 2016
Primary Completion
April 1, 2021
Study Completion
April 1, 2022
Last Updated
May 19, 2020
Record last verified: 2020-05