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Completed

NCT Number: NCT04943419

Myeloid-derived Suppressor Cells in Colorectal Cancer

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Complication,Postoperative Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Radiotherapy Rectal Diseases Suppression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

1st Department of General Surgery

Krakow, Malopolska, 31-501, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Level of Myeloid-Derived Suppressor Cells

Diagnostic Test

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

Primary outcomes

  1. Level of MDSC in patients with postoperative complications

    Time frame: 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 outcomes

  1. Level of MDSC in patients with severe postoperative complications

    Time frame: 30 days

    Level of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio in patients with severe postoperative complications (Clavien-Dindo>= IIIA)

  2. Level of MDSC in patients with severe septic postoperative complications

    Time frame: 30 days

    Level of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio in patients with severe postoperative complications (Clavien-Dindo>= IIIA) with infection

  3. Level of MDSC in patients after neoadjuvant therapy

    Time frame: 1 day before surgery

    Level of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio in patients after neoadjuvant treatment

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

    Time frame: 1 day before surgery

    Level of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio in patients with tumours T2-T4 after neoadjuvant treatment

  5. Level of MDSC measured in the specimen

    Time frame: 1 day

    evel of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio measured in the specimen after resection

  6. Level of MDSC in patients with left and right sided tumours

    Time frame: 1 day

    evel of all MDSC, PNMMDSC, MMDSC, EMDSC and M/PMNMDSC ratio measured in patients with left-sided and right-sided colorectal cancer

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2021
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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