Given Indication for Gastroesophageal Cancer SurgeryNCT01249534
Diagnostic Value of C-reactive Protein for Detection of Postoperative Inflammatory Complications After Gastroesophageal Cancer Surgery
An observational study of Given Indication for Gastroesophageal Cancer Surgery, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive protein (CRP) in the postoperative course. The aim of this study was to evaluate the diagnostic accuracy of CRP for postoperative inflammatory complications after gastroesophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Given Indication for Gastroesophageal Cancer Surgery
- What is being tested?
- gastroesophageal cancer surgery
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2010to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Given indication for gastroesophageal cancer surgery
Who may be able to join
- all patients with gastroesophageal cancer surgery
Who cannot join
- lack of measurement of C-reactive protein
Trial locations and contacts
1 site in 1 country.
About this study
Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive protein (CRP) in the postoperative course. The aim of this study was to evaluate the diagnostic accuracy of CRP for postoperative inflammatory complications after gastroesophageal cancer.
- Being tested
- gastroesophageal cancer surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastroesophageal cancer surgeryOther
gastroesophageal cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients after gastroesophageal cancer surgery | Not described Receives: Other: gastroesophageal cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative Inflammatory complications
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Given Indication for Gastroesophageal Cancer SurgeryStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Investigators
- Rene Warschkow, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249534
- Sponsor's protocol ID
- EKSG10/144
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of C-reactive Protein for Detection of Postoperative Inflammatory Complications After Gastroesophageal Cancer Surgery
- ClinicalTrials.gov ID
- NCT01249534
- Acronym / sponsor ID
- EKSG10/144
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Nov 2010 (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.
Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive protein (CRP) in the postoperative course. The aim of this study was to evaluate the diagnostic accuracy of CRP for postoperative inflammatory complications after gastroesophageal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after gastroesophageal cancer surgery | – | Other: gastroesophageal cancer surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Given indication for gastroesophageal cancer surgery
Key inclusion criteria (1 listed)
- all patients with gastroesophageal cancer surgery
Key exclusion criteria (1 listed)
- lack of measurement of C-reactive protein
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 |
|---|---|---|
| gastroesophageal cancer surgerygastroesophageal cancer surgery | Other | Patients after gastroesophageal cancer surgery |
Primary outcome
postoperative Inflammatory complications
Time frame: 30 days postoperatively
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 10 Dec 2010.
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.
Rene Warschkow, MD principal investigator
Cantonal Hospital of St. Gallen
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 Given Indication for Gastroesophageal Cancer Surgery, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 10 Dec 2010. 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 Switzerland. 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 Inflammatory complications (time frame: 30 days postoperatively). 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 10 Dec 2010.