Gastric CancerNCT04989153
Nasal Endoscopic Screening and Risk Assessment for Early Gastric Cancer
An observational study of Gastric Cancer and Precancerous Lesion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 sites in China.
Trial summary
Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Gastric Cancer, Precancerous Lesion, Helicobacter Pylori Infection
- What is being tested?
- pepsinogen
- Type of treatment
- Injection or infusion
- How many people
- 5,000 participants
- Where
- 9 sitesChina
- Study dates
- 5 Mar 2016to 6 Dec 2023
- How long will I take part?
- 6 Years
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive subjects who underwent regular health checkup at nine International Healthcare Centers in different regions of China
Who may be able to join
- intention to undergo gastroscopy during health checkup examination 25-75 years of age.
Who cannot join
- a history of gastric ulcer, gastric polyp, or GC a history of gastrectomy treatment with a proton pump inhibitor in the last month contraindications to gastroscopy a history of Hp eradication a history of abdominal pain, abdominal distention, belching, acid reflux, nausea and other digestive tract symptoms within 1 month incomplete data.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Hong Li
- Recruiting
Sichuan Provincial People's Hospital
Chengdu
Lirong Gong
- Recruiting
The First Hospital affiliated to AMU (Southwest Hospital)
Chongqing
Hongbo Wu
- Recruiting
No. 924 Hospital of the People's Liberation Army of China
Guilin
Xueqiang He
- Recruiting
Jilin City People's Hospital
Jilin City, Jilin
Hongguang Wang, 406346148@qq.com
- Recruiting
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou
Yinhu Luo
- Recruiting
Kunshan Hospital of Traditional Chinese Medicine
Kunshan
Hongwei Xu
- Recruiting
Shanghai Changhai Hospital
Shanghai
Dong Wang
- Recruiting
Zhongshan Hospital affiliated to Xiamen University
Xiamen
Hongzhi Xu
About this study
Official title: China Health Promotion Foundation/the Second Affiliated Hospital of Zhejiang University, School of Medicine
Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China.
Read the detailed description
Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China. We operated a multicenter cross-sectional study of subjects who underwent health checkup at nine International Healthcare Centers in China. All participants underwent gastroscopy and pathological examination, serum PG, 13C-urea breath test, and/or Hp serological current infection marker rapid test, all on the same day. PG related parameters were analyzed in different Hp subgroups and regions.
- Being tested
- pepsinogen
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pepsinogenDiagnostic test
serum pepsinogen diagnosed gastric cancer and precanceous lesion
| Study group | Role | What they receive |
|---|---|---|
| non-atrophic gastritis | No atrophic gastritis, The OLGA-0 group;OLGA :Operative Link on Gastritis Assessment) | |
| mild-moderate atrophic gastritis | The OLGA I-II group;OLGA :Operative Link on Gastritis Assessment) | |
| severe atrophic gastritis | The OLGA III-IV group;OLGA :Operative Link on Gastritis Assessment) Receives: Diagnostic Test: pepsinogen | |
| gastric cancer | gastric cancer Receives: Diagnostic Test: pepsinogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum pepsinogen levels for GC and precancerous lesions
cutoff values of pepsinogen level for GC and precancerous lesions in different regions in China and in different HP status
Measured: 1 year
Risk factors for GC
the risk factors for GC, according to the logistic regression model
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start5 Mar 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion6 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 5,000 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jilin City People's Hospital, No. 924 Hospital of the People's Liberation Army of China, Kunshan Hospital of Traditional Chinese Medicine, Chinese PLA General Hospital, Sichuan Provincial People's Hospital, Affiliated Hospital of Southwest Medical University, Zhongshan Hospital Xiamen University, Jingzhou Hospital of Traditional Chinese Medicine, Changhai Hospital
- Responsible party
- Sponsor
- Investigators
- Yi Zhao, Master, Principal investigator, 2nd affiliated hospital of Zhejiang university, school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989153
- Sponsor's protocol ID
- 研2015-079
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Health Promotion Foundation/the Second Affiliated Hospital of Zhejiang University, School of Medicine
- ClinicalTrials.gov ID
- NCT04989153
- Acronym / sponsor ID
- 研2015-079
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Jilin City People's Hospital, No. 924 Hospital of the People's Liberation Army of China, Kunshan Hospital of Traditional Chinese Medicine, Chinese PLA General Hospital, Sichuan Provincial People's Hospital, Affiliated Hospital of Southwest Medical University, Zhongshan Hospital Xiamen University, Jingzhou Hospital of Traditional Chinese Medicine, Changhai Hospital
- Study start
- 5 Mar 2016 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 6 Dec 2023 (estimated)
- First posted
- 4 Aug 2021 (actual)
- 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.
Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China.
Detailed description
Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China. We operated a multicenter cross-sectional study of subjects who underwent health checkup at nine International Healthcare Centers in China. All participants underwent gastroscopy and pathological examination, serum PG, 13C-urea breath test, and/or Hp serological current infection marker rapid test, all on the same day. PG related parameters were analyzed in different Hp subgroups and regions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-atrophic gastritis | – | –No atrophic gastritis, The OLGA-0 group;OLGA :Operative Link on Gastritis Assessment) |
| mild-moderate atrophic gastritis | – | –The OLGA I-II group;OLGA :Operative Link on Gastritis Assessment) |
| severe atrophic gastritis | – | Diagnostic Test: pepsinogenThe OLGA III-IV group;OLGA :Operative Link on Gastritis Assessment) |
| gastric cancer | – | Diagnostic Test: pepsinogengastric cancer |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive subjects who underwent regular health checkup at nine International Healthcare Centers in different regions of China
Key inclusion criteria (1 listed)
- intention to undergo gastroscopy during health checkup examination 25-75 years of age.
Key exclusion criteria (1 listed)
- a history of gastric ulcer, gastric polyp, or GC a history of gastrectomy treatment with a proton pump inhibitor in the last month contraindications to gastroscopy a history of Hp eradication a history of abdominal pain, abdominal distention, belching, acid reflux, nausea and other digestive tract symptoms within 1 month incomplete data.
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 |
|---|---|---|
| pepsinogenserum pepsinogen diagnosed gastric cancer and precanceous lesion | Diagnostic test | gastric cancer, severe atrophic gastritis |
Primary outcome
serum pepsinogen levels for GC and precancerous lesions
Time frame: 1 year
cutoff values of pepsinogen level for GC and precancerous lesions in different regions in China and in different HP status
Risk factors for GC
Time frame: 1 year
the risk factors for GC, according to the logistic regression model
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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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.
Yi Zhao, Master principal investigator
2nd affiliated hospital of Zhejiang university, school of medicine
9 sites 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 and Precancerous Lesion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Contact Zhenya Song, Dr. (13600529612, songzhenya@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum pepsinogen levels for GC and precancerous lesions (time frame: 1 year). The study lists 2 primary outcomes in all. 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 4 Aug 2021.