Stomach NeoplasmsNCT04439812
Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer
An observational study of Stomach Neoplasms, run by Hospital Universitario Ramon y Cajal.
Trial summary
Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It has been suggested that positive surgical margins is an adverse prognosis factor, with a higher local recurrence and worse overall survival (OS). However, the management of these patients remains unclear. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Observation
- How many people
- 267 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.
Who may be able to join
- all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.
Who cannot join
- distant disease (including patients with positive cytology), early postoperative mortality (within 30 days after surgery) and follow-up data not available. Resections in patients with palliative intent were also excluded.
About this study
Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It has been suggested that positive surgical margins is an adverse prognosis factor, with a higher local recurrence and worse overall survival (OS). However, the management of these patients remains unclear.
- Conditions
- Stomach Neoplasms
- Being tested
- Observation
- Keywords
- Gastric cancer, gastrectomy, R1, positive margins, recurrence, overall survival, prognosis
- Medical subject headings
- Stomach Neoplasms, Margins of Excision, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
The primary aim of this study was to evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC. The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| R=0 | Patients without positive margins after gastrectomy for gastric cancer Receives: Other: Observation | |
| R=1 | Patients with positive margins after gastrectomy for gastric cancer Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC
Measured: 8 years
Secondary outcomes (1)
The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jan 2010
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Priego, Hospital Universitario Ramon y Cajal
- Investigators
- Pablo Priego, MD, PhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439812
- Sponsor's protocol ID
- 186/20
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT04439812
- Acronym / sponsor ID
- 186/20
- Conditions
- Stomach Neoplasms
- Keywords
- Gastric cancer, gastrectomy, R1, positive margins, recurrence, overall survival, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Jun 2020 (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.
Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It has been suggested that positive surgical margins is an adverse prognosis factor, with a higher local recurrence and worse overall survival (OS). However, the management of these patients remains unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R=0 | – | Other: ObservationPatients without positive margins after gastrectomy for gastric cancer |
| R=1 | – | Other: ObservationPatients with positive margins after gastrectomy for gastric cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.
Key inclusion criteria (1 listed)
- all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.
Key exclusion criteria (1 listed)
- distant disease (including patients with positive cytology), early postoperative mortality (within 30 days after surgery) and follow-up data not available. Resections in patients with palliative intent were also excluded.
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 |
|---|---|---|
| ObservationThe primary aim of this study was to evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC. The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy. | Other | R=0, R=1 |
Primary outcome
evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC
Time frame: 8 years
1 secondary outcome
The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.
Time frame: 8 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 19 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Pablo Priego, MD, PhD principal investigator
Hospital Universitario Ramon y Cajal
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms, run by Hospital Universitario Ramon y Cajal.
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 19 Jun 2020. 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?
evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC (time frame: 8 years). 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 Jun 2020.