Colonic NeoplasmsNCT00860691
Double Blinded Randomized Clinical Trial of the Effect of Open Versus Laparoscopic Colectomy on Neutrophils in Patients With Colon Cancer
A study testing Therapeutic conventional colorectal surgery, Therapeutic laparoscopic colorectal surgery and Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest in people with Colonic Neoplasms, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
The purpose of this study is: to determine neutrophil activity in patients with colon cancer, to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon cancer patients and establish its prognostic value, to elucidate the relationship between serum sFas, sFasL and IL - 17 levels and… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Therapeutic conventional colorectal surgery, Therapeutic laparoscopic colorectal surgery and Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- Jan 2008to Jun 2010
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients will be informed that additional blood and tissue samples will be taken during perioperative period for colon cancer research, and written consent will be obtained. Informed consent will be also obtained from each healthy volunteer.
- Patients with the clinical diagnosis of colorectal cancer based on colonoscopy following histological confirmation will recruited. They should be suitable for elective surgical resection of the tumour along with lymph node dissection by right and left hemicolectomy, sigmoid colectomy, and anterior resection. Clinicopathologic characteristics of these patients will be investigated based on TNM classification of malignant tumours and modified Dukes classification Inclusion criteria; age between 18 and 80 years; colorectal cancer with single tumour locating at cecum, ascending colon, descending colon, sigmoid colon or recto sigmoid junction (distance from anal verge more than 15 cm); ASA I-III; and informed consent.
- Exclusion criteria; patient refusal to participate in the prospective data collection; prior midline laparotomy; emergency surgery or urgent operation within 24 h after admission to the hospital; conversion to laparotomy; mechanic ileus; perforation or abscess with septic inflammatory response syndrome; planned stoma, low anterior resection or rectal extirpation; known immunological dysfunction (human immunodeficiency virus infection); presence of ongoing infection or infective chronic diseases; severe cardiovascular disease (New York Heart Association class higher than 3) or pulmonary insufficiency (severe pulmonary emphysema, interstitial pneumonitis, arterial PO2<79 mmHg); advanced liver disease (Child-Pugh class C); synchronous or metachronous (within five years) malignancy; pregnant or lactating women; continuous systemic steroid therapy; drug addiction; previous chemotherapy, radiotherapy or immune therapy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital "Dubrava"
Zagreb, 10 000
Igor Stipancic, MD, PhD, Professor, +3851290 2517, igors@kbd.hr
Valentina Ratkajec, MD, +3851290 3612, vratkajec@kbd.hr
About this study
The purpose of this study is:
- to determine neutrophil activity in patients with colon cancer,
- to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon cancer patients and establish its prognostic value,
- to elucidate the relationship between serum sFas, sFasL and IL - 17 levels and clinicopathologic features of colon cancer,
- to compare the influence of laparoscopic and conventional procedures on postoperative serum sFas and sFasL levels in colon cancer patients
- to compare the influence of laparoscopic and conventional procedures on postoperative serum IL - 17 levels in colon cancer patients
- to compare the influence of laparoscopic and conventional procedures on postoperative neutrophil functions
- to confirm the expression of FasL protein in human colorectal cancer and elucidate the relationship between FasL expression and clinicopathologic features of the disease, to establish the prevalence of Fas in primary colon adenocarcinomas and elucidate the relationship between FasL expression and clinicopathologic features of the disease
- to determine the functional activity of tumour infiltrating neutrophils
Read the detailed description
Colorectal cancer is the leading cause of death worldwide. Tumour cell extravasation plays a key role in tumour metastasis. There are evidences tumour cell-leukocyte interactions may support tumour cell invasion and could create an optimal microenvironment for tumour growth at the metastatic site. Neutrophils produce free radicals and proteases; they could cause tumour cytolysis, as well as promote tumour growth and metastasis. It seems that neutrophils play an important role in the context of tumour and angiogenesis.
It is not well understood why FasL induces immune privilege in some organs but elicits inflammation. To explain these apparently conflicting phenomena, it is important to investigate the mechanism of FasL-induced inflammation in detail. Fas/FasL can serve as potential targets for effective antitumor therapy. This research will be useful to eludicate the importance of neutrophil in colorectal cancer. We will investigate the possible role of neutrophil activity and FasL-induced neutrophil infiltration on tumor growth in colorectal cancer. sFas and sFasL could be a way to measure the balance of apoptotic and immunoescape effect after surgical resection of colon cancer.
If the number of neutrophils in peripheral blood mirrors the situation in the tumor tissue, these data could support the investigation of neutrophil-targeted therapies in anti-cancer strategy.
Inflammation-dependent angiogenesis seems to be a central force in tumor growth and expansion, a concept supported by the observation that the use of anti-inflammatory drugs, leads to angiogenesis inhibition. The mechanisms of inflammatory angiogenesis could provide new approaches to target, cure, or prevent tumor angiogenesis. Investigation of the physiologic regulation of IL-17 may thus be useful for the treatment in clinical settings characterized by persistent neovascularisation.
Inhibition of neutrophil elastase might not only reduce the inflammatory response, but could also prevent cancer cell progression. Anti-neutrophil elastase therapy after tumour resection might be an important strategic approach for managing postoperative complications and preventing cancer recurrence.
Patients will be allocated to laparoscopic or conventional open colorectal surgery after eligibility had been confirmed and informed consent given. Randomization will be performed by computer; sequencing was based on a list of variable block sizes for a single centre without further stratification. The randomization list and opaque envelopes will be generated by independent personnel not otherwise involved in the trial. Information on the operation will be remain in consecutively numbered and sealed envelopes that will be stored in a specific box at the clinical site. The envelope containing the allocation will be added to a patient's file shortly before he or she enter the operating theatre. The envelope will be then open and the surgeon will perform the assigned procedure. Until the day of discharge of participants, nurses and other medical staff will be blinded for the type of surgery performed in patients with colorectal cancer by applying a covering abdominal bandage.
During the trial, all blood samples will be retrieved and assessed by a cytologist and molecular biologist blinded to the study arms.
- Conditions
- Colonic Neoplasms
- Being tested
- Therapeutic conventional colorectal surgery, Therapeutic laparoscopic colorectal surgery, Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest
- Keywords
- Curative surgical resection, Laparoscopic technique
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic conventional colorectal surgeryProcedure or surgery
Also called Open colorectal surgery
Patients with colorectal cancer undergo open laparotomy and colorectal resection
Therapeutic laparoscopic colorectal surgeryProcedure or surgery
Patients with colorectal cancer undergo laparoscopic colorectal resection
Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and BursttestOther
Informed consent will be obtained.Blood samples will be obtained at one time point. .Samples will be processed to serum, using a refrigerated centrifuge, then stored at -80C until analysis. Peripheral blood samples for measurement of oxidative burst in neutrophils will be collected into heparinised blood tube.Serum concentrations of sFas will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fas MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R\&D Systems Inc, Minneapolis, USA). Serum concentrations of sFasL will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fasl MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R\&D Systems Inc, Minneapolis, USA).Respiratory burst neutrophil production will be determined quantitatively by flow cytometry using a commercial kit Bursttest Kit (Cat. No: 10-0200; ORPEGEN Pharma, Germany)
| Study group | Role | What they receive |
|---|---|---|
| ARM I - Open colorectal surgery | Active comparator | Open colorectal surgery Receives: Procedure: Therapeutic conventional colorectal surgery |
| ARM II - Laparoscopic colorectal surgery | Experimental | Laparoscopic colorectal surgery Receives: Procedure: Therapeutic laparoscopic colorectal surgery |
| Control - reference value | Other | Blood samples from healthy volunteers will be obtained at one time point.Peripheral blood samples will be obtained into tubes with no additive (BD Vacutainer System, Plymouth, UK).Samples will be processed to serum. Serum concentrations of sFas will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA)using specific anti-Fas MoAbs, Human sFas Immunoassay. Serum concentrations of sFasL will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fasl MoAbs, Human sFas Immunoassay. Serum concentration of IL - 17 will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using Human IL-17 Immunoassay. . Peripheral blood samples for measurement of oxidative burst in neutrophils will be collected into heparinised blood tube. burst neutrophil production will be determined quantitatively by flow cytometry as described by Rothe using a commercial kit Bursttest Kit. Receives: Other: Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil activity before and after the open or laparoscopic surgery - Serum concentrations of sFas, sFasL and IL - 17.
Measured: 24 hours before surgery, 72 hours after surgery
Respiratory burst neutrophil production - Bursttest before and after open or laparoscopic surgery
Measured: 24 hours before surgery and 2 hours after surgery
Immunohistochemical detection of FasL in tumor and paratumor areas of colon cancer and normal colon mucosa taken at a distance of 10 cm from the tumor
Measured: after surgery
Immunohistochemical detection of Fas in tumor and paratumor areas of colon cancer and normal colon mucosa taken at a distance of 10 cm from the tumor
Measured: after surgery
Immunohistochemical detection of neutrophil elastase in tumor and paratumor areas of colon cancer and normal colon mucosa taken at a distance of 10 cm from the tumor
Measured: after surgery
Number of leukocytes, neutrophils, lymphocytes and neutrophils/lymphocytes ratio
Measured: 24 hours before surgery, 2 hours after surgery, 72 hours after surgery
CRP
Measured: 24 hours before surgery, 72 hours after surgery
Fe, transferrin, ferritin
Measured: 24 hours before surgery, 72 hours after surgery
Secondary outcomes (10)
to determine neutrophil activity in patients with colon cancer and healthy volunteers
Measured: 24 hours before surgery, 2 hours and 72 hours after surgery
to compare the influence of laparoscopic and conventional procedures on postoperative neutrophil function
Measured: 24 hours before surgery, 2 hours and 72 hours after surgery
to determine functional activity of tumour infiltrating neutrophils
Measured: after surgery
to determine an effect of surgery on neutrophil activity
Measured: 24 hours before surgery, 2 hours and 72 hours after surgery
to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon cancer patients and establish its prognostic value
Measured: 24 hours before surgery, 2 hours and 72 hours after surgery
to eludicate the relationship between serum sFas, sFasL and IL - 17 levels and clinicopathologic features of colon cancer
Measured: 24 hours before surgery, 2 hours and 72 hours after surgery
to compare the influence of laparoscopic and conventional procedures on postoperative serum sFas, sFasL and IL - 17 levels in colon cancer patients
Measured: 24 hours before surgery, 2 hours and 72 hours after surgery
to confirm the expression of FasL protein in human colorectal cancer and elucidate the relationship between FasL expression and clinicopathologic features of the disease
Measured: after surgery
to establish the prevalence of Fas in primary colon adenocarcinomas and elucidate the relationship between Fas expression and clinicopathologic features of the disease
Measured: after surgery
loss of blood during the surgery, postoperative hospital stay, morbidity, and mortality within 30 days after surgery
Measured: intraoperative and within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science, Education and Sport, Republic of Croatia
- Investigators
- Igor Stipančić, MD, PhD, Profssor, Study chair, University Hospital DubravaValentina Ratkajec, MD, Principal investigator, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860691
- Sponsor's protocol ID
- 198-0000000-3104
- Status last verified
- Mar 2010
- First submitted
- 10 Mar 2009
- Last updated
- 26 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Clinical Trial of the Effect of Open Versus Laparoscopic Colectomy on Neutrophils in Patients With Colon Cancer
- ClinicalTrials.gov ID
- NCT00860691
- Acronym / sponsor ID
- 198-0000000-3104
- Conditions
- Colonic Neoplasms
- Keywords
- Curative surgical resection, Laparoscopic technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Collaborators
- Ministry of Science, Education and Sport, Republic of Croatia
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 12 Mar 2009 (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.
The purpose of this study is:
- to determine neutrophil activity in patients with colon cancer,
- to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon cancer patients and establish its prognostic value,
- to elucidate the relationship between serum sFas, sFasL and IL - 17 levels and clinicopathologic features of colon cancer,
- to compare the influence of laparoscopic and conventional procedures on postoperative serum sFas and sFasL levels in colon cancer patients
- to compare the influence of laparoscopic and conventional procedures on postoperative serum IL - 17 levels in colon cancer patients
- to compare the influence of laparoscopic and conventional procedures on postoperative neutrophil functions
- to confirm the expression of FasL protein in human colorectal cancer and elucidate the relationship between FasL expression and clinicopathologic features of the disease, to establish the prevalence of Fas in primary colon adenocarcinomas and elucidate the relationship between FasL expression and clinicopathologic features of the disease
- to determine the functional activity of tumour infiltrating neutrophils
Detailed description
Colorectal cancer is the leading cause of death worldwide. Tumour cell extravasation plays a key role in tumour metastasis. There are evidences tumour cell-leukocyte interactions may support tumour cell invasion and could create an optimal microenvironment for tumour growth at the metastatic site. Neutrophils produce free radicals and proteases; they could cause tumour cytolysis, as well as promote tumour growth and metastasis. It seems that neutrophils play an important role in the context of tumour and angiogenesis.
It is not well understood why FasL induces immune privilege in some organs but elicits inflammation. To explain these apparently conflicting phenomena, it is important to investigate the mechanism of FasL-induced inflammation in detail. Fas/FasL can serve as potential targets for effective antitumor therapy. This research will be useful to eludicate the importance of neutrophil in colorectal cancer. We will investigate the possible role of neutrophil activity and FasL-induced neutrophil infiltration on tumor growth in colorectal cancer. sFas and sFasL could be a way to measure the balance of apoptotic and immunoescape effect after surgical resection of colon cancer.
If the number of neutrophils in peripheral blood mirrors the situation in the tumor tissue, these data could support the investigation of neutrophil-targeted therapies in anti-cancer strategy.
Inflammation-dependent angiogenesis seems to be a central force in tumor growth and expansion, a concept supported by the observation that the use of anti-inflammatory drugs, leads to angiogenesis inhibition. The mechanisms of inflammatory angiogenesis could provide new approaches to target, cure, or prevent tumor angiogenesis. Investigation of the physiologic regulation of IL-17 may thus be useful for the treatment in clinical settings characterized by persistent neovascularisation.
Inhibition of neutrophil elastase might not only reduce the inflammatory response, but could also prevent cancer cell progression. Anti-neutrophil elastase therapy after tumour resection might be an important strategic approach for managing postoperative complications and preventing cancer recurrence.
Patients will be allocated to laparoscopic or conventional open colorectal surgery after eligibility had been confirmed and informed consent given. Randomization will be performed by computer; sequencing was based on a list of variable block sizes for a single centre without further stratification. The randomization list and opaque envelopes will be generated by independent personnel not otherwise involved in the trial. Information on the operation will be remain in consecutively numbered and sealed envelopes that will be stored in a specific box at the clinical site. The envelope containing the allocation will be added to a patient's file shortly before he or she enter the operating theatre. The envelope will be then open and the surgeon will perform the assigned procedure. Until the day of discharge of participants, nurses and other medical staff will be blinded for the type of surgery performed in patients with colorectal cancer by applying a covering abdominal bandage.
During the trial, all blood samples will be retrieved and assessed by a cytologist and molecular biologist blinded to the study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM I - Open colorectal surgery | Active comparator | Procedure: Therapeutic conventional colorectal surgeryOpen colorectal surgery |
| ARM II - Laparoscopic colorectal surgery | Experimental | Procedure: Therapeutic laparoscopic colorectal surgeryLaparoscopic colorectal surgery |
| Control - reference value | Other | Other: Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and BursttestBlood samples from healthy volunteers will be obtained at one time point.Peripheral blood samples will be obtained into tubes with no additive (BD Vacutainer System, Plymouth, UK).Samples will be processed to serum. Serum concentrations of sFas will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA)using specific anti-Fas MoAbs, Human sFas Immunoassay. Serum concentrations of sFasL will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fasl MoAbs, Human sFas Immunoassay. Serum concentration of IL - 17 will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using Human IL-17 Immunoassay. . Peripheral blood samples for measurement of oxidative burst in neutrophils will be collected into heparinised blood tube. burst neutrophil production will be determined quantitatively by flow cytometry as described by Rothe using a commercial kit Bursttest Kit. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients will be informed that additional blood and tissue samples will be taken during perioperative period for colon cancer research, and written consent will be obtained. Informed consent will be also obtained from each healthy volunteer.
- Patients with the clinical diagnosis of colorectal cancer based on colonoscopy following histological confirmation will recruited. They should be suitable for elective surgical resection of the tumour along with lymph node dissection by right and left hemicolectomy, sigmoid colectomy, and anterior resection. Clinicopathologic characteristics of these patients will be investigated based on TNM classification of malignant tumours and modified Dukes classification Inclusion criteria; age between 18 and 80 years; colorectal cancer with single tumour locating at cecum, ascending colon, descending colon, sigmoid colon or recto sigmoid junction (distance from anal verge more than 15 cm); ASA I-III; and informed consent.
- Exclusion criteria; patient refusal to participate in the prospective data collection; prior midline laparotomy; emergency surgery or urgent operation within 24 h after admission to the hospital; conversion to laparotomy; mechanic ileus; perforation or abscess with septic inflammatory response syndrome; planned stoma, low anterior resection or rectal extirpation; known immunological dysfunction (human immunodeficiency virus infection); presence of ongoing infection or infective chronic diseases; severe cardiovascular disease (New York Heart Association class higher than 3) or pulmonary insufficiency (severe pulmonary emphysema, interstitial pneumonitis, arterial PO2<79 mmHg); advanced liver disease (Child-Pugh class C); synchronous or metachronous (within five years) malignancy; pregnant or lactating women; continuous systemic steroid therapy; drug addiction; previous chemotherapy, radiotherapy or immune therapy.
Key exclusion criteria (0 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 |
|---|---|---|
| Therapeutic conventional colorectal surgeryAlso: Open colorectal surgeryPatients with colorectal cancer undergo open laparotomy and colorectal resection | Procedure or surgery | ARM I - Open colorectal surgery |
| Therapeutic laparoscopic colorectal surgeryPatients with colorectal cancer undergo laparoscopic colorectal resection | Procedure or surgery | ARM II - Laparoscopic colorectal surgery |
| Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and BursttestInformed consent will be obtained.Blood samples will be obtained at one time point. .Samples will be processed to serum, using a refrigerated centrifuge, then stored at -80C until analysis. Peripheral blood samples for measurement of oxidative burst in neutrophils will be collected into heparinised blood tube.Serum concentrations of sFas will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fas MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R\&D Systems Inc, Minneapolis, USA). Serum concentrations of sFasL will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fasl MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R\&D Systems Inc, Minneapolis, USA).Respiratory burst neutrophil production will be determined quantitatively by flow cytometry using a commercial kit Bursttest Kit (Cat. No: 10-0200; ORPEGEN Pharma, Germany) | Other | Control - reference value |
Primary outcome
Neutrophil activity before and after the open or laparoscopic surgery - Serum concentrations of sFas, sFasL and IL - 17.
Time frame: 24 hours before surgery, 72 hours after surgery
Respiratory burst neutrophil production - Bursttest before and after open or laparoscopic surgery
Time frame: 24 hours before surgery and 2 hours after surgery
Immunohistochemical detection of FasL in tumor and paratumor areas of colon cancer and normal colon mucosa taken at a distance of 10 cm from the tumor
Time frame: after surgery
Immunohistochemical detection of Fas in tumor and paratumor areas of colon cancer and normal colon mucosa taken at a distance of 10 cm from the tumor
Time frame: after surgery
Immunohistochemical detection of neutrophil elastase in tumor and paratumor areas of colon cancer and normal colon mucosa taken at a distance of 10 cm from the tumor
Time frame: after surgery
Number of leukocytes, neutrophils, lymphocytes and neutrophils/lymphocytes ratio
Time frame: 24 hours before surgery, 2 hours after surgery, 72 hours after surgery
CRP
Time frame: 24 hours before surgery, 72 hours after surgery
Fe, transferrin, ferritin
Time frame: 24 hours before surgery, 72 hours after surgery
10 secondary outcomes
to determine neutrophil activity in patients with colon cancer and healthy volunteers
Time frame: 24 hours before surgery, 2 hours and 72 hours after surgery
to compare the influence of laparoscopic and conventional procedures on postoperative neutrophil function
Time frame: 24 hours before surgery, 2 hours and 72 hours after surgery
to determine functional activity of tumour infiltrating neutrophils
Time frame: after surgery
to determine an effect of surgery on neutrophil activity
Time frame: 24 hours before surgery, 2 hours and 72 hours after surgery
to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon cancer patients and establish its prognostic value
Time frame: 24 hours before surgery, 2 hours and 72 hours after surgery
to eludicate the relationship between serum sFas, sFasL and IL - 17 levels and clinicopathologic features of colon cancer
Time frame: 24 hours before surgery, 2 hours and 72 hours after surgery
to compare the influence of laparoscopic and conventional procedures on postoperative serum sFas, sFasL and IL - 17 levels in colon cancer patients
Time frame: 24 hours before surgery, 2 hours and 72 hours after surgery
to confirm the expression of FasL protein in human colorectal cancer and elucidate the relationship between FasL expression and clinicopathologic features of the disease
Time frame: after surgery
to establish the prevalence of Fas in primary colon adenocarcinomas and elucidate the relationship between Fas expression and clinicopathologic features of the disease
Time frame: after surgery
loss of blood during the surgery, postoperative hospital stay, morbidity, and mortality within 30 days after surgery
Time frame: intraoperative and within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2010.
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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.
Igor Stipančić, MD, PhD, Profssor study chair
University Hospital Dubrava
Valentina Ratkajec, MD 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?
A study testing Therapeutic conventional colorectal surgery, Therapeutic laparoscopic colorectal surgery and Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest in people with Colonic Neoplasms, 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 26 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor Stipancic, MD, PhD, Professor (+3851290 2517, igors@kbd.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil activity before and after the open or laparoscopic surgery - Serum concentrations of sFas, sFasL and IL - 17. (time frame: 24 hours before surgery, 72 hours after surgery). The study lists 8 primary outcomes in all. 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 26 Mar 2010; AzTrials last refreshed its copy on 7 Nov 2026.