Myeloid-derived Suppressor Cells in Colorectal Cancer

Completed

• Conditions: Complication,Postoperative; Suppression; Colorectal Cancer; Radiotherapy
• Interventions: Diagnostic Test: Level of Myeloid-Derived Suppressor Cells

• Registration Number: NCT04943419
• Lead Sponsor: Jagiellonian University

Brief Summary

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

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).

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2021-02-27
• Study Completion: 2021-06-21
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-06-29
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-03
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal cancer	Level of Myeloid-Derived Suppressor Cells	Patients with colorectal cancer qualified for elective operations.

Primary Outcome Measures

Name	Time	Method
Level of MDSC in patients with postoperative complications	30 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

1st Department of General Surgery; 🇵🇱 Krakow, Malopolska, Poland