Colorectal CancerNCT01244022
Cytokine Changes After Colorectal Cancer Resection
An observational study of Colorectal Cancer, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
Based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- colorectal cancer resection
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteCroatia
- Study dates
- Aug 2010to Dec 2012
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal cancer treated in the University Hospital Dubrava
Who may be able to join
- Pathohistologically verified colorectal cancer
Who cannot join
- Distant metastases noticed before or during surgery
- History of autoimmune diseases or immunodeficiencies
- Use of immunomodulatory drugs within 1 year prior to surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer
Based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer.
Read the detailed description
Every surgical intervention represents a stress for patient's organism. During the operation, numerous changes in the patient's metabolism take place, that are termed surgical stress response. Leading cause of surgical stress response is tissue destruction that always accompanies operations. Surgical stress response is effected through activation of hypothalamus-pituitary-adrenal axis and through sympathetic activation.
The consequences of surgical stress response are numerous. Surgical stress response is essential to uneventful postoperative recovery. On the other hand, excessive surgical stress response may lead to serious postoperative complications, such as heart and kidney failure, venous thrombosis, disruption of operative wound and wound infection.
In prior studies the investigators have shown the kinetics of postoperative serum interleukin changes after radical resection of gastric cancer.
This study aims at determining reliable markers of surgical stress response severity in patients undergoing radical resection of colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- colorectal cancer resection
- Keywords
- Colorectal cancer, Surgical stress response, interleukins
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colorectal cancer resectionProcedure or surgery
Also called Hemicolectomy, Rectosigmoid resection
Open radical resection of colorectal cancer, according to oncological principals, depending on the tumor site
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer patients | Patients with pathohistologically verified colorectal cancer or adenoma with epithelial dysplasia Receives: Procedure: colorectal cancer resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative changes of serum cytokine levels
Serum cytokine levels will be determined at 1st, 2nd and 7th postoperative day and compared to preoperative values.
Measured: 1 day, 2 days and 7 days postoperatively
Secondary outcomes (1)
Early postoperative complications
Measured: Within one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drazen Servis, University Hospital Dubrava
- Investigators
- Drazen Servis, M.D., Ph.D., Principal investigator, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244022
- Sponsor's protocol ID
- DS-P03112010
- Status last verified
- Jul 2013
- First submitted
- 12 Nov 2010
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Servis D, Busic Z, Stipancic I, Patrlj L, Gagro A. Serum cytokine changes after gastric resection or gastrectomy for gastric cancer. Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1868-72.
PubMed 19102411Etherek L, Servis D, Unic A. Soluble Triggering Receptor Expressed on Myeloid Cells-1 and Inflammatory Markers in Colorectal Cancer Surgery: A Prospective Cohort Study. Chin Med J (Engl). 2017 Nov 20;130(22):2691-2696. doi: 10.4103/0366-6999.218022.
PubMed 29133757
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01244022
- Acronym / sponsor ID
- DS-P03112010
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Surgical stress response, interleukins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 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.
Based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer.
Detailed description
Every surgical intervention represents a stress for patient's organism. During the operation, numerous changes in the patient's metabolism take place, that are termed surgical stress response. Leading cause of surgical stress response is tissue destruction that always accompanies operations. Surgical stress response is effected through activation of hypothalamus-pituitary-adrenal axis and through sympathetic activation.
The consequences of surgical stress response are numerous. Surgical stress response is essential to uneventful postoperative recovery. On the other hand, excessive surgical stress response may lead to serious postoperative complications, such as heart and kidney failure, venous thrombosis, disruption of operative wound and wound infection.
In prior studies the investigators have shown the kinetics of postoperative serum interleukin changes after radical resection of gastric cancer.
This study aims at determining reliable markers of surgical stress response severity in patients undergoing radical resection of colorectal cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | – | Procedure: colorectal cancer resectionPatients with pathohistologically verified colorectal cancer or adenoma with epithelial dysplasia |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer treated in the University Hospital Dubrava
Key inclusion criteria (1 listed)
- Pathohistologically verified colorectal cancer
Key exclusion criteria (3 listed)
- Distant metastases noticed before or during surgery
- History of autoimmune diseases or immunodeficiencies
- Use of immunomodulatory drugs within 1 year prior to 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 |
|---|---|---|
| colorectal cancer resectionAlso: Hemicolectomy, Rectosigmoid resectionOpen radical resection of colorectal cancer, according to oncological principals, depending on the tumor site | Procedure or surgery | Colorectal cancer patients |
Primary outcome
Postoperative changes of serum cytokine levels
Time frame: 1 day, 2 days and 7 days postoperatively
Serum cytokine levels will be determined at 1st, 2nd and 7th postoperative day and compared to preoperative values.
1 secondary outcome
Early postoperative complications
Time frame: Within one month after surgery
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 Jul 2013.
- Background: PubMed 19102411Servis D, Busic Z, Stipancic I, Patrlj L, Gagro A. Serum cytokine changes after gastric resection or gastrectomy for gastric cancer. Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1868-72.
- Derived from this study: PubMed 29133757Etherek L, Servis D, Unic A. Soluble Triggering Receptor Expressed on Myeloid Cells-1 and Inflammatory Markers in Colorectal Cancer Surgery: A Prospective Cohort Study. Chin Med J (Engl). 2017 Nov 20;130(22):2691-2696. doi: 10.4103/0366-6999.218022.
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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.
Drazen Servis, M.D., Ph.D. principal investigator
University Hospital Dubrava
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 Colorectal Cancer, run by University Hospital Dubrava at 1 site in Croatia.
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 3 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 Jul 2013. 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 Croatia. 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 changes of serum cytokine levels (time frame: 1 day, 2 days and 7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01244022, which also lists 2 linked publications.
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 Jul 2013.