Gastric CancerNCT03046745
Gastric Cancer Registry for Epidemiology and Molecular Risk Factor
An observational study of Gastric Cancer, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 9,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Apr 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- The patients who were diagnosed of primary gastric adenocarcinoma and drew up agreement for understanding and enrollment of this study.
Who cannot join
- Being treated (surgery, endoscopic resection and chemoradiation) after the diagnosis of gastric cancer; metastatic gastric cancer; refusal to participation of this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seong Woo Jeon
Daegu
Seong Woo Jeon, Ph.D., sw-jeon@hanmail.net
About this study
Official title: Analysis and Prediction of Epidemiology and Molecular Biologic Risks of Gastric Cancer by Multicenter Registry
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
- To evaluate the optimal interval of endoscopic screening for early detection of gastric cancer and risk factors in Korean.
- 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.
Read the detailed description
Gastric cancer (GC) is the fourth most common type of cancer (934 000 new cases, 8.6% of all new cancer cases in 2002), and the second most common cause of cancer death (700 000 deaths annually) in the world. Several Asian countries, including China, Japan, and Korea, have the highest incidences of GC in the world. Because the prognosis of early GC is highly favorable, high- prevalence countries, such as Japan and Korea, have sought to reduce the disease burden by providing GC screening to aver- age-risk populations. In Korea, national GC screening was instituted in 1999 as part of the National Cancer Screening Program (NCSP). The NCSP recommends biennial GC screening for males and females older than 40 years of age, using direct or indirect upper gastrointestinal series (UGIS) or endoscopy. Upper gastrointestinal endoscopies are generally accepted as the gold standard for the diagnosis and clinicopathological evaluation of GC. Endoscopic examination has been predominantly used to screen symptomatic individuals, and to distinguish patients with GC from those with comparatively benign diseases, such as peptic ulcers. However, there was no consensus for optimal timing of screening endoscopy to detect of early GC.
Thus, investigators are planned to evaluate the optimal endoscopic interval to find early gastric cancer by use of survey between newly diagnosed GC cohort group and healthy control cohort group. In addition, investigators are going to analyze the risk factors of GC in Korean (epidemiologic, diet, and clinical factors). In this study, the investigators are going to enroll the participants who were diagnosed GC and normal control group people, from October 2016 to October 2021 in multi-center, prospectively. The baseline characteristics of the participants, H. pylori status, stage of gastric cancer at diagnosis, treatment modalities, treatment response and mortality were analyzed.
Although diagnosis of gastric cancer has been characterized by endoscopy, there has been a strong demand for serologic marker because accessibility, invasiveness, discomfort of endoscopy. In recent years, there have been advancements in the molecular biomarkers utilized in the cancer detection and in the development of therapeutic agents based on the target genes for a few types of solid tumours excluding GC. With the advancement of molecular biological techniques in the last decades, researchers have gained important insights into the oncogenesis mechanisms of GC. Besides the well-known pathogenic factor, Helicobacter pylori, various experimental approaches have identified oncogenes and tumour suppressor genes, including cell cycle regulation genes in the growth and signal transduction pathways. Recently, several studies were reported about the efficacy of the serum biomarker (serum PG, H. pylori Ig G Antibody and TFF3, etc) for diagnosis of GC. In this present study, investigators are going to the efficacy of serum biomarker by the use of serum of GC patients and health control group.
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, endoscopy, pepsinogen, TFF3, biomarker
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of risk factors for gastric cancer and definition of optimal endoscopic screening interval
Measured: Up to 5 years
Secondary outcomes (9)
The diagnostic validity of serum biomarker (serum pepsinogen and TFF3) for detection of gastric cancer
Measured: up to 5 years
Analysis of proportion of each treatment of gastric cancer and 5 year survival
Investigators should analyze the treatment patterns (endoscopic resection, surgery, chemotherapy or supportive care) of gastric cancer and assess the survival rate according to each treatment modalities.
Measured: up to 10 years
Analysis of quality of life questionnaire after early gastric cancer between endoscopic treatment group and surgery group
Investigators should measure QOL of the enrolled patients with EORTC questionnaire and compare the changing trends in each groups, prospectively.
Measured: up to 6 years
the incidence of gastric cancer development in control group
Measured: up to 20 years
the incidence of metachronous gastric neoplasm after endoscopic treatment or surgery
Measured: up to 10 years
Analysis of clinical differences and characteristics between positive gastric cancer family history and negative family history groups
Measured: up to 5 years
Stage, treatment and prognosis of gastric cancer according to molecular classification
Measured: up to 10 years
Stage, treatment and prognosis of gastric cancer according to endoscopic screening interval
Measured: up to 10 years
Reservation of frozen serum for novel gastric cancer serologic marker analysis
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startAug 2016
- Primary completionApr 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Seong Woo Jeon, Kyungpook National University Hospital
- Investigators
- Seong Woo Jeon, Professor, Principal investigator, Gastric Cancer Center, Kyungpook National University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046745
- Sponsor's protocol ID
- KNUMC 2016-07-014
- Status last verified
- May 2020
- First submitted
- 5 Feb 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 23800201Forman 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.
PubMed 2059685Parsonnet 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.
PubMed 1891020Helicobacter 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.
PubMed 11511555Lee 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.
PubMed 26836587Dhillon 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.
PubMed 11391635Minami 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.
PubMed 14529588Iijima 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.
PubMed 19440811Nam 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.
PubMed 39375058Lee 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.
PubMed 29977284
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis and Prediction of Epidemiology and Molecular Biologic Risks of Gastric Cancer by Multicenter Registry
- ClinicalTrials.gov ID
- NCT03046745
- Acronym / sponsor ID
- KNUMC 2016-07-014
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, endoscopy, pepsinogen, TFF3, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Aug 2016
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 8 Feb 2017 (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.
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
- To evaluate the optimal interval of endoscopic screening for early detection of gastric cancer and risk factors in Korean.
- 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.
Detailed description
Gastric cancer (GC) is the fourth most common type of cancer (934 000 new cases, 8.6% of all new cancer cases in 2002), and the second most common cause of cancer death (700 000 deaths annually) in the world. Several Asian countries, including China, Japan, and Korea, have the highest incidences of GC in the world. Because the prognosis of early GC is highly favorable, high- prevalence countries, such as Japan and Korea, have sought to reduce the disease burden by providing GC screening to aver- age-risk populations. In Korea, national GC screening was instituted in 1999 as part of the National Cancer Screening Program (NCSP). The NCSP recommends biennial GC screening for males and females older than 40 years of age, using direct or indirect upper gastrointestinal series (UGIS) or endoscopy. Upper gastrointestinal endoscopies are generally accepted as the gold standard for the diagnosis and clinicopathological evaluation of GC. Endoscopic examination has been predominantly used to screen symptomatic individuals, and to distinguish patients with GC from those with comparatively benign diseases, such as peptic ulcers. However, there was no consensus for optimal timing of screening endoscopy to detect of early GC.
Thus, investigators are planned to evaluate the optimal endoscopic interval to find early gastric cancer by use of survey between newly diagnosed GC cohort group and healthy control cohort group. In addition, investigators are going to analyze the risk factors of GC in Korean (epidemiologic, diet, and clinical factors). In this study, the investigators are going to enroll the participants who were diagnosed GC and normal control group people, from October 2016 to October 2021 in multi-center, prospectively. The baseline characteristics of the participants, H. pylori status, stage of gastric cancer at diagnosis, treatment modalities, treatment response and mortality were analyzed.
Although diagnosis of gastric cancer has been characterized by endoscopy, there has been a strong demand for serologic marker because accessibility, invasiveness, discomfort of endoscopy. In recent years, there have been advancements in the molecular biomarkers utilized in the cancer detection and in the development of therapeutic agents based on the target genes for a few types of solid tumours excluding GC. With the advancement of molecular biological techniques in the last decades, researchers have gained important insights into the oncogenesis mechanisms of GC. Besides the well-known pathogenic factor, Helicobacter pylori, various experimental approaches have identified oncogenes and tumour suppressor genes, including cell cycle regulation genes in the growth and signal transduction pathways. Recently, several studies were reported about the efficacy of the serum biomarker (serum PG, H. pylori Ig G Antibody and TFF3, etc) for diagnosis of GC. In this present study, investigators are going to the efficacy of serum biomarker by the use of serum of GC patients and health control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- The patients who were diagnosed of primary gastric adenocarcinoma and drew up agreement for understanding and enrollment of this study.
Key exclusion criteria (1 listed)
- Being treated (surgery, endoscopic resection and chemoradiation) after the diagnosis of gastric cancer; metastatic gastric cancer; refusal to participation of this study
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
Prediction of risk factors for gastric cancer and definition of optimal endoscopic screening interval
Time frame: Up to 5 years
9 secondary outcomes
The diagnostic validity of serum biomarker (serum pepsinogen and TFF3) for detection of gastric cancer
Time frame: up to 5 years
Analysis of proportion of each treatment of gastric cancer and 5 year survival
Time frame: up to 10 years
Analysis of quality of life questionnaire after early gastric cancer between endoscopic treatment group and surgery group
Time frame: up to 6 years
the incidence of gastric cancer development in control group
Time frame: up to 20 years
the incidence of metachronous gastric neoplasm after endoscopic treatment or surgery
Time frame: up to 10 years
Analysis of clinical differences and characteristics between positive gastric cancer family history and negative family history groups
Time frame: up to 5 years
Stage, treatment and prognosis of gastric cancer according to molecular classification
Time frame: up to 10 years
Stage, treatment and prognosis of gastric cancer according to endoscopic screening interval
Time frame: up to 10 years
Reservation of frozen serum for novel gastric cancer serologic marker analysis
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Results publication: PubMed 23800201Lim 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.
- Results publication: PubMed 2059685Forman 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.
- Results publication: PubMed 1891020Parsonnet 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.
- Results publication: PubMed 11511555Helicobacter 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.
- Results publication: PubMed 26836587Lee 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.
- Results publication: PubMed 11391635Dhillon 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.
- Results publication: PubMed 14529588Minami 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.
- Results publication: PubMed 19440811Iijima 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.
- Derived from this study: PubMed 39375058Nam 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.
- Derived from this study: PubMed 29977284Lee 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.
- Individual participant dataSharing planned: Undecided
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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.
Seong Woo Jeon, Professor principal investigator
Gastric Cancer Center, Kyungpook National University Medical Center
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 Cancer, run by Kyungpook 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 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 19 May 2020. 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 Seong Woo Jeon, Professor (+82-53-200-3089, sw-jeon@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of risk factors for gastric cancer and definition of optimal endoscopic screening interval (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046745, which also lists 10 linked publications.
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 19 May 2020.