Gastric CancerGCSEPNCT03777540
Gastric Cancer Surgery in Elderly Patients
An observational study of Gastric Cancer, run by University of Bologna.
Trial summary
Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in aged population because of general health condition may affect the postoperative result. 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 resection
- Type of treatment
- Surgery or procedure
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Jun 2018
- 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
- No healthy volunteers
- Older adult
Study population: 236 patients (181: 80-85 years old and 55: >85 years old) underwent surgery for gastric cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015.
Who may be able to join
- Patients with histologically confirmed primary gastric cancer submitted to surgical treatment;
- Age > 80 years.
Who cannot join
- Patients with histologically confirmed primary gastric cancer submitted to surgical treatment and age < 80 years;
- Patients with histologically diagnosis of other neoplastic and non-neoplastic diseases submitted to surgical treatment.
About this study
Official title: Post-Operative Outcomes And Predictors Of Mortality After Gastric Cancer Surgery In The Very Elderly Patients
Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in aged population because of general health condition may affect the postoperative result. Aim of the study was to identify risk factors for post-operative mortality in octogenarian patients who underwent surgery for gastric cancer.
Read the detailed description
236 patients (181: 80-85 years old and 55: >85 years old) underwent surgery for gastric cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015. The variables of the two groups of patients were compared.
- Conditions
- Gastric Cancer
- Being tested
- Gastric resection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric resectionProcedure or surgery
Partial gastrectomy with jejunal anastomosis," "total gastrectomy," "gastroenterostomy without gastrectomy" or "other" (palliative surgery).
| Study group | Role | What they receive |
|---|---|---|
| Age; timing of gastric resection | Patients 80-85 years; Patients > 85 years; Elective and urgent surgery. Receives: Procedure: Gastric resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative mortality In-hospital mortality was defined that occurred during hospitalization up to 90 days excluded post-operative mortality. Postoperative mortality
mortality occurred up to 90 days from surgery
Measured: Up to 90-days
Secondary outcomes (1)
Overall survival
Overall survival was defined as the time from the date of surgery to patient death (including surgery-associated death or hospital death), or the date of last available information concerning vital status.
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 posted17 Dec 2018
- Study start1 Jan 2010
- Primary completion31 Dec 2015
- Study completion30 Jun 2018
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.
- 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marialuisa Lugaresi, University of Bologna
- Investigators
- Bruno Nardo, MD,PhD, Study chair, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777540
- Sponsor's protocol ID
- Gastric Cancer Surgery
- Acronym
- GCSEP
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Outcomes And Predictors Of Mortality After Gastric Cancer Surgery In The Very Elderly Patients
- ClinicalTrials.gov ID
- NCT03777540
- Acronym / sponsor ID
- GCSEP / Gastric Cancer Surgery
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 17 Dec 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.
Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in aged population because of general health condition may affect the postoperative result. Aim of the study was to identify risk factors for post-operative mortality in octogenarian patients who underwent surgery for gastric cancer.
Detailed description
236 patients (181: 80-85 years old and 55: >85 years old) underwent surgery for gastric cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015. The variables of the two groups of patients were compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age; timing of gastric resection | – | Procedure: Gastric resectionPatients 80-85 years; Patients > 85 years; Elective and urgent surgery. |
Who may qualify
- Ages
- 80 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 236 patients (181: 80-85 years old and 55: >85 years old) underwent surgery for gastric cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015.
Key inclusion criteria (2 listed)
- Patients with histologically confirmed primary gastric cancer submitted to surgical treatment;
- Age > 80 years.
Key exclusion criteria (2 listed)
- Patients with histologically confirmed primary gastric cancer submitted to surgical treatment and age < 80 years;
- Patients with histologically diagnosis of other neoplastic and non-neoplastic diseases submitted to surgical 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 |
|---|---|---|
| Gastric resectionPartial gastrectomy with jejunal anastomosis," "total gastrectomy," "gastroenterostomy without gastrectomy" or "other" (palliative surgery). | Procedure or surgery | Age; timing of gastric resection |
Primary outcome
Post-operative mortality In-hospital mortality was defined that occurred during hospitalization up to 90 days excluded post-operative mortality. Postoperative mortality
Time frame: Up to 90-days
mortality occurred up to 90 days from surgery
1 secondary outcome
Overall survival
Time frame: Up to 5-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 17 Dec 2018.
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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.
Bruno Nardo, MD,PhD study chair
University of Bologna
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by University of Bologna.
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 2 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 17 Dec 2018. 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?
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?
Post-operative mortality In-hospital mortality was defined that occurred during hospitalization up to 90 days excluded post-operative mortality. Postoperative mortality (time frame: Up to 90-days). 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 17 Dec 2018.