NCT04943419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

4.9 years

First QC Date

June 21, 2021

Last Update Submit

July 3, 2022

Conditions

Colorectal CancerSuppressionComplication,PostoperativeRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Level of MDSC in patients with severe postoperative complications

    30 days

  • Level of MDSC in patients with severe septic postoperative complications

    30 days

  • Level of MDSC in patients after neoadjuvant therapy

    1 day before surgery

  • Level of MDSC in patients with T2-T4 tumours after neoadjuvant treatment

    1 day before surgery

  • Level of MDSC measured in the specimen

    1 day

  • +1 more secondary outcomes

Study Arms (1)

Colorectal cancer

Patients with colorectal cancer qualified for elective operations.

Diagnostic Test: Level of Myeloid-Derived Suppressor Cells

Interventions

Level of Myeloid-Derived Suppressor CellsDIAGNOSTIC_TEST

Establishing of levels of all MDSC, PMNMDSC, MMDSC, EMDSC, M/PMN MDSC ratio on the day before operation.

Colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histologically-confirmed colorectal cancer who undergo elective surgery.

You may qualify if:

  • age ≥ 18
  • colorectal cancer confirmed by histological examination of biopsy specimen
  • elective operation
  • signed informed consent

You may not qualify if:

  • Age \< 18
  • Pregnancy or lactation
  • Emergency operation
  • General condition that precludes understanding and signing of the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Department of General Surgery

Krakow, Malopolska, 31-501, Poland

Location

Related 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 Nov;26(11):2354-2357. doi: 10.1007/s11605-022-05364-3. Epub 2022 Jun 1. No abstract available.

    PMID: 35650461RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Radoslaw Pach, Ph.D.

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 29, 2021

Study Start

April 1, 2016

Primary Completion

February 27, 2021

Study Completion

June 21, 2021

Last Updated

July 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)