Gastric CancerNCT03978481
Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study
An observational study of Gastric Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Helicobacter pylori eradication (combination therapy)
- How many people
- 3,700 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2019to 30 Apr 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status in Seoul National University Bundang Hospital, from 2003 to 2018
Who may be able to join
- Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status
Who cannot join
- Patients with other severe diseases (other primary cancer, severe cardiovascular, cerebral, renal, hepatic diseases)
- Patients received palliative treatment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication.
Read the detailed description
In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication. In addition, we will analyze the correlation between the incidence and survival rate of this type of stomach cancer by comparing smoking, gastric cancer direct family history, disease stage (TNM staging), the histologic type of stomach cancer (intestinal, diffuse, mixed), and the surgical method (Billoth I, Billoth II) as well as the infection and eradication status of H. pylori.
- Conditions
- Gastric Cancer
- Being tested
- Helicobacter pylori eradication (combination therapy)
- Keywords
- Gastric cancer, Helicobacter pylori, Subtotal gastrectomy, Overall survival, Metachronous cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helicobacter pylori eradication (combination therapy)Combination product
Antibiotic eradication therapy (triple or quadriple regimen)
| Study group | Role | What they receive |
|---|---|---|
| Eradicated group | Gastric cancer patients received subtotal gastrectomy, with Helicobacter pylori eradication Receives: Combination Product: Helicobacter pylori eradication (combination therapy) | |
| Negative group | Gastric cancer patients received subtotal gastrectomy, without Helicobacter pylori eradication or Helicobacter pylori negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: From date of initial curative surgery for gastric cancer, until the date of death from any cause, up to 60 months
Secondary outcomes (2)
Gastric cancer-specific (disease-free) survival
Survival period without cancer recurrence or newly developed stomach cancer diagnosis
Measured: From date of initial curative surgery for gastric cancer, until the date of diagnosis of gastric cancer recurrence or the date of death, whichever comes first, up to 60 months
Metachronous cancer (remnant stomach cancer)
The number of patients who were diagnosed with new carcinoma on the remnant stomach, over follow-up period of up to 60 months, in eradication group and non-eradication group
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start30 Jan 2019
- Primary completion30 Jan 2020
- Study completion30 Apr 2020
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 Seoul National University Bundang HospitalThe 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
- Retrospective
- Enrolment
- 3,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978481
- Sponsor's protocol ID
- B-1902-523-107
- Status last verified
- Mar 2021
- First submitted
- 2 Jun 2019
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Helicobacter Pylori Eradication After Subtotal Gastrectomy on Survival Rate of Gastric Cancer Patients: Retrospective Study
- ClinicalTrials.gov ID
- NCT03978481
- Acronym / sponsor ID
- B-1902-523-107
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Helicobacter pylori, Subtotal gastrectomy, Overall survival, Metachronous cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,700 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 7 Jun 2019 (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.
In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication.
Detailed description
In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication. In addition, we will analyze the correlation between the incidence and survival rate of this type of stomach cancer by comparing smoking, gastric cancer direct family history, disease stage (TNM staging), the histologic type of stomach cancer (intestinal, diffuse, mixed), and the surgical method (Billoth I, Billoth II) as well as the infection and eradication status of H. pylori.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eradicated group | – | Combination Product: Helicobacter pylori eradication (combination therapy)Gastric cancer patients received subtotal gastrectomy, with Helicobacter pylori eradication |
| Negative group | – | –Gastric cancer patients received subtotal gastrectomy, without Helicobacter pylori eradication or Helicobacter pylori negative |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status in Seoul National University Bundang Hospital, from 2003 to 2018
Key inclusion criteria (1 listed)
- Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status
Key exclusion criteria (2 listed)
- Patients with other severe diseases (other primary cancer, severe cardiovascular, cerebral, renal, hepatic diseases)
- Patients received palliative treatment
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 |
|---|---|---|
| Helicobacter pylori eradication (combination therapy)Antibiotic eradication therapy (triple or quadriple regimen) | Combination product | Eradicated group |
Primary outcome
Overall survival
Time frame: From date of initial curative surgery for gastric cancer, until the date of death from any cause, up to 60 months
2 secondary outcomes
Gastric cancer-specific (disease-free) survival
Time frame: From date of initial curative surgery for gastric cancer, until the date of diagnosis of gastric cancer recurrence or the date of death, whichever comes first, up to 60 months
Metachronous cancer (remnant stomach cancer)
Time frame: Up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Seoul National University Bundang 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 2 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: finished, as of the sponsor's last update on 29 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of initial curative surgery for gastric cancer, until the date of death from any cause, up to 60 months). 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 29 Nov 2024.