Early Gastric CancerNCT02090062
Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection
An observational study of Early Gastric Cancer, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our study aims to determine the difference in H. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Early Gastric Cancer
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Sep 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with early gastric lesions
Who may be able to join
- high grade dysplasia(HGD) and EGC patients treated by endoscopic resection(including EMR and ESD) in Ren Ji hospital
Who cannot join
- Suspect of advanced gastric cancer
- Lesions with light grade dysplasia
- History of gastric surgery
- Poor gastrointestinal preparation
- Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc
Trial locations and contacts
No sites are listed yet.
About this study
Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our study aims to determine the difference in H. pylori infection rate of EGC patients before and after ER , and discuss the causes leading to the difference, which can provide references for improving the diagnostic accuracy of H. pylori infection and reducing EGC's recurrence rate.
Read the detailed description
Gastric cancer is the fourth most commonly diagnosed cancer in the world and the second leading cause of cancer-related deaths. Nowadays, endoscopic resection（ER） is widely accepted as the primary treatment for early gastric cancer (EGC) without lymph node metastasis，which includes endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).However, recurrence rate after endoscopic resection for EGC still achieves 6.7%-14%. However, there is no comparative analysis about H. pylori infection rate before and after ER yet.
- Conditions
- Early Gastric Cancer
- Keywords
- endoscopic resection, H. pylori infection
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in H. pylori infection rate before and after ER
Information on the H pylori infection status before ER will be collected from the medical records of each patient. A positive result on at least one rapid urease test, urease breath test or Giemsa staining is deemed to be indicative of H pylori infection .Each specimen after ER will be detected H pylori infection status in two weeks. Then we analyze the difference in H. pylori infection rate before and after ER.
Measured: in two weeks after endoscopic resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Li, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiaobo Li, MD.Ph.D, Principal investigator, Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090062
- Sponsor's protocol ID
- rjxhnk2014
- Status last verified
- Mar 2014
- First submitted
- 13 Mar 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection
- ClinicalTrials.gov ID
- NCT02090062
- Acronym / sponsor ID
- rjxhnk2014
- Conditions
- Early Gastric Cancer
- Keywords
- endoscopic resection, H. pylori infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 18 Mar 2014 (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.
Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our study aims to determine the difference in H. pylori infection rate of EGC patients before and after ER , and discuss the causes leading to the difference, which can provide references for improving the diagnostic accuracy of H. pylori infection and reducing EGC's recurrence rate.
Detailed description
Gastric cancer is the fourth most commonly diagnosed cancer in the world and the second leading cause of cancer-related deaths. Nowadays, endoscopic resection（ER） is widely accepted as the primary treatment for early gastric cancer (EGC) without lymph node metastasis，which includes endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).However, recurrence rate after endoscopic resection for EGC still achieves 6.7%-14%. However, there is no comparative analysis about H. pylori infection rate before and after ER yet.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with early gastric lesions
Key inclusion criteria (1 listed)
- high grade dysplasia(HGD) and EGC patients treated by endoscopic resection(including EMR and ESD) in Ren Ji hospital
Key exclusion criteria (5 listed)
- Suspect of advanced gastric cancer
- Lesions with light grade dysplasia
- History of gastric surgery
- Poor gastrointestinal preparation
- Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc
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
difference in H. pylori infection rate before and after ER
Time frame: in two weeks after endoscopic resection
Information on the H pylori infection status before ER will be collected from the medical records of each patient. A positive result on at least one rapid urease test, urease breath test or Giemsa staining is deemed to be indicative of H pylori infection .Each specimen after ER will be detected H pylori infection status in two weeks. Then we analyze the difference in H. pylori infection rate before and after ER.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Xiaobo Li, MD.Ph.D principal investigator
Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai,China
Questions about this trial
What is this clinical trial studying?
An observational study of Early Gastric Cancer, run by Shanghai Jiao Tong University School of Medicine.
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 5 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 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaobo Li, MD.Ph.D (86-21-58752345, lxb_1969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in H. pylori infection rate before and after ER (time frame: in two weeks after endoscopic resection). 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 19 Mar 2014.