Clinical trial NCT04943419: Myeloid-derived Suppressor Cells in Colorectal Cancer
Official title: Myeloid-derived Suppressor Cells in Colorectal Cancer: Influence on Postoperative Complications and Neoadjuvant Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Suppression
Complication,Postoperative
Radiotherapy
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically-confirmed colorectal cancer who undergo elective surgery.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Level of MDSC in patients with postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Level of MDSC in patients with severe postoperative complications
timeFrame: 30 days
measure: Level of MDSC in patients with severe septic postoperative complications
timeFrame: 30 days
measure: Level of MDSC in patients after neoadjuvant therapy
timeFrame: 1 day before surgery
measure: Level of MDSC in patients with T2-T4 tumours after neoadjuvant treatment
timeFrame: 1 day before surgery
measure: Level of MDSC measured in the specimen
timeFrame: 1 day
measure: Level of MDSC in patients with left and right sided tumours
timeFrame: 1 day
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: 1st Department of General Surgery
state: Malopolska
Study officials:
affiliation: Jagiellonian University
name: Radoslaw Pach, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogala J, Sieminska I, Baran J, Rubinkiewicz M, Zybaczynska J, Szczepanik AM, Pach R. Myeloid-Derived Suppressor Cells May Predict the Occurrence of Postoperative Complications in Colorectal Cancer Patients-a Pilot Study. J Gastrointest Surg. 2022 Nov;26(11):2354-2357. doi: 10.1007/s11605-022-05364-3. Epub 2022 Jun 1. No abstract available.