Gastric CancerNCT03639792
Escorting Octogenarian for Gastric Cancer Surgery
An observational study of Gastric Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients. Read more about this study
- Who is it for?
- Ages 80 to 90 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- gastric cancer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2017
- 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 80 to 90 years
- All sexes
- Older adult
Study population: A cohort of gastric cancer patients who underwent surgery during two consecutive years in a Chinese hospital.
Who may be able to join
- Pathologically confirmed gastric cancer patients Clinically fit for gastric cancer surgery
Who cannot join
- Non gastric cancer patients Clinically unfit for gastric cancer surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients.
Read the detailed description
An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients. Detailed data on surgical indication, assessment for proposed surgery and perioperative management are analyzed for future guidelines in senile.
- Conditions
- Gastric Cancer
- Being tested
- gastric cancer surgery
- Keywords
- gastric cancer, postoperative complication, octogenarian
- Medical subject headings
- Stomach Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric cancer surgeryProcedure or surgery
Gastric cancer surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Morbidity and mortality
Postoperative Morbidity and mortality according to standard definition
Measured: One month after hospital discharge
Secondary outcomes (1)
Overall survival
Overall survival
Measured: upto two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 Ruijin 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
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BIRENDRA KUMAR SAH, Ruijin Hospital
- Investigators
- Birendra K Sah, Ph D, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639792
- Sponsor's protocol ID
- RJ-GC-Postop-complication 2
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escorting Octogenarian for Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT03639792
- Acronym / sponsor ID
- RJ-GC-Postop-complication 2
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, postoperative complication, octogenarian
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 21 Aug 2018 (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.
An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients.
Detailed description
An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients. Detailed data on surgical indication, assessment for proposed surgery and perioperative management are analyzed for future guidelines in senile.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 to 90 years
- Sex
- All
- Age groups
- Older adult
- Study population
- A cohort of gastric cancer patients who underwent surgery during two consecutive years in a Chinese hospital.
Key inclusion criteria (1 listed)
- Pathologically confirmed gastric cancer patients Clinically fit for gastric cancer surgery
Key exclusion criteria (1 listed)
- Non gastric cancer patients Clinically unfit for gastric cancer surgery
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 |
|---|---|---|
| gastric cancer surgeryGastric cancer surgery | Procedure or surgery | – |
Primary outcome
Postoperative Morbidity and mortality
Time frame: One month after hospital discharge
Postoperative Morbidity and mortality according to standard definition
1 secondary outcome
Overall survival
Time frame: upto two years
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 22 May 2020.
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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.
Birendra K Sah, Ph D principal investigator
Ruijin Hospital
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 Ruijin Hospital at 1 site 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: finished, as of the sponsor's last update on 22 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 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?
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?
Postoperative Morbidity and mortality (time frame: One month after hospital discharge). 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 22 May 2020.