An observational study in Colorectal Cancer, Suppression and Complication,Postoperative, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-07.
Sponsored by Jagiellonian University · Observational
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.
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).
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 90 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with histologically-confirmed colorectal cancer who undergo elective surgery.
Exclusion Criteria:
Patients with colorectal cancer qualified for elective operations.
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.
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
Time frame: 30 days
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 day
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Jagiellonian University