Myeloid-derived Suppressor Cells in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04943419
• Other study ID #: Colorectal MDSC
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: June 21, 2021

Study information

• Verified date: July 2022
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 21, 2021
• Est. primary completion date: February 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Complication,Postoperative
• Postoperative Complications
• Radiotherapy

Intervention

Diagnostic Test:
• Level of Myeloid-Derived Suppressor Cells
Establishing of levels of all MDSC, PMNMDSC, MMDSC, EMDSC, M/PMN MDSC ratio on the day before operation.

Locations

Country	Name	City	State
Poland	1st Department of General Surgery	Krakow	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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 Jun 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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