Myeloid-derived Suppressor Cells in Colorectal Cancer

Study Overview
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Brief Summary
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The aim of the study is to evaluate whether the preoperative level of myeloid-derived suppressor cells is associated with postoperative complications classified by Clavien-Dindo categories. Levels of all MDSC, polymorphonuclear MDSC (PMNMDSC), monocytic MDSC (MMDSC), early-stage MDSC (EMDSC) and monocytic to polymorphonuclear MDSC ratio (M/PMN MDCS) were established and compared in patients with postoperative complications, severe postoperative complications (>= IIIA according to Clavien-Dindo) and severe septic complications.

Detailed Description
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Levels of all MDSC, polymorphonuclear MDSC (PMNMDSC), monocytic MDSC (MMDSC), early-stage MDSC (EMDSC) and monocytic to polymorphonuclear MDSC ratio (M/PMN MDCS) were established and compared in patients with and without postoperative complications. Then subgroup analysis was performed to compare levels of MDSC in patients with severe postoperative complications (>= IIIA according to Clavien-Dindo) and those without severe complications. Another subgroup analysis will be performed for patients with severe septic complications that are defined as severe complications with accompanying infection. Levels of MDSC will be compared by means of U Mann Whitney test as their distribution is not normal. After above mentioned analyses it will be possible to evaluate the role of MDSC in patients with colorectal cancer in terms of postoperative complications. Additional analyse will be performed to compare levels of MDSC in patients who underwent neoadjuvant treatment (radiotherapy or chemoradiotherapy).

Official Title
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Myeloid-derived Suppressor Cells in Colorectal Cancer: Influence on Postoperative Complications and Neoadjuvant Treatment

Conditions
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Colorectal Cancer, Suppression, Complication,Postoperative, Radiotherapy

Intervention / Treatment
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* Diagnostic Test: Level of Myeloid-Derived Suppressor Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 colorectal cancer confirmed by histological examination of biopsy specimen elective operation signed informed consent Exclusion Criteria: Age < 18 Pregnancy or lactation Emergency operation General condition that precludes understanding and signing of the informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal cancer<br>Patients with colorectal cancer qualified for elective operations. | Diagnostic Test: Level of Myeloid-Derived Suppressor Cells<br>* Establishing of levels of all MDSC, PMNMDSC, MMDSC, EMDSC, M/PMN MDSC ratio on the day before operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of MDSC in patients with postoperative complications | Level of all MDSC, polymorphonuclear MDSC (PNMMDSC), monocytic MDSC ( MMDSC), early-stage MDSC (EMDSC) and monocytic to polymorphonuclear MDSC ratio (M/PMNMDSC) in patients with postoperative complications | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of MDSC in patients with severe postoperative complications | Level of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio in patients with severe postoperative complications (Clavien-Dindo>= IIIA) | 30 days | 
| Level of MDSC in patients with severe septic postoperative complications | Level of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio in patients with severe postoperative complications (Clavien-Dindo>= IIIA) with infection | 30 days | 
| Level of MDSC in patients after neoadjuvant therapy | Level of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio in patients after neoadjuvant treatment | 1 day before surgery | 
| Level of MDSC in patients with T2-T4 tumours after neoadjuvant treatment | Level of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio in patients with tumours T2-T4 after neoadjuvant treatment | 1 day before surgery | 
| Level of MDSC measured in the specimen | evel of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio measured in the specimen after resection | 1 day | 
| Level of MDSC in patients with left and right sided tumours | evel of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio measured in patients with left-sided and right-sided colorectal cancer | 1 day |