Regulation of Inflammatory ResponseNCT01419431
Attenuated Inflammatory Response in Laparoscopic Colon Surgery
An observational study of Regulation of Inflammatory Response, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Pro-inflammatory responses following laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regulation of Inflammatory Response
- What is being tested?
- Laparoscopic resection
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Dec 2011
- 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: Colon cancer stage I-III
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increased SOCS 3 mRNA in Monocytes From Patients Subjected to Laparoscopic Colon Surgery
Pro-inflammatory responses following laparoscopic surgery.
Read the detailed description
Blood samples from 20 patient with colon cancer collected before and in 3 days following laparoscopic surgery. Analyzed for inflammatory cytokines and corresponding SOCS3 mRNA.
- Conditions
- Regulation of Inflammatory Response
- Being tested
- Laparoscopic resection
- Keywords
- Colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic resectionProcedure or surgery
Also called Colon cancer
Inflammatory response in laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Colon cancer patients | Laparoscopic resection Receives: Procedure: Laparoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory values for laparoscopic resection for colon cancer.
Corresponding values of SOCS3 mRNA copared to inflammatory cytokines in patients with laparoscopic resection for colon cancer.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startJan 2007
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regulation of Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dag T Førland, Oslo University Hospital
- Investigators
- Dag T. Førland, MD, Principal investigator, OUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419431
- Sponsor's protocol ID
- SOCS3 mRNA
- Other IDs
- SOCS-3-202008
- Status last verified
- Dec 2011
- First submitted
- 18 Jul 2011
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased SOCS 3 mRNA in Monocytes From Patients Subjected to Laparoscopic Colon Surgery
- ClinicalTrials.gov ID
- NCT01419431
- Acronym / sponsor ID
- SOCS3 mRNA
- Conditions
- Regulation of Inflammatory Response
- Keywords
- Colon cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Aug 2011 (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.
Pro-inflammatory responses following laparoscopic surgery.
Detailed description
Blood samples from 20 patient with colon cancer collected before and in 3 days following laparoscopic surgery. Analyzed for inflammatory cytokines and corresponding SOCS3 mRNA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colon cancer patients | – | Procedure: Laparoscopic resectionLaparoscopic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colon cancer stage I-III
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Laparoscopic resectionAlso: Colon cancerInflammatory response in laparoscopic surgery | Procedure or surgery | Colon cancer patients |
Primary outcome
Inflammatory values for laparoscopic resection for colon cancer.
Time frame: 3 days
Corresponding values of SOCS3 mRNA copared to inflammatory cytokines in patients with laparoscopic resection for colon cancer.
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 16 Dec 2011.
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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.
Dag T. Førland, MD principal investigator
OUS
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 Regulation of Inflammatory Response, run by Oslo University Hospital at 1 site in Norway.
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 0 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 16 Dec 2011. 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 Norway. 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?
Inflammatory values for laparoscopic resection for colon cancer. (time frame: 3 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 16 Dec 2011.