Colorectal CancerNCT04943419
Myeloid-derived Suppressor Cells in Colorectal Cancer
An observational study of Colorectal Cancer and Suppression, run by Jagiellonian University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Suppression, Complication,Postoperative
- What is being tested?
- Level of Myeloid-Derived Suppressor Cells
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2016to 21 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically-confirmed colorectal cancer who undergo elective surgery.
Who may be able to join
- age ≥ 18
- colorectal cancer confirmed by histological examination of biopsy specimen
- elective operation
- signed informed consent
Who cannot join
- Age < 18
- Pregnancy or lactation
- Emergency operation
- General condition that precludes understanding and signing of the informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myeloid-derived Suppressor Cells in Colorectal Cancer: Influence on Postoperative Complications and Neoadjuvant Treatment
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.
Read the 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).
- Being tested
- Level of Myeloid-Derived Suppressor Cells
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer | Patients with colorectal cancer qualified for elective operations. Receives: Diagnostic Test: Level of Myeloid-Derived Suppressor Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (6)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Apr 2016
- Primary completion27 Feb 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radoslaw Pach, MD, Ph D, Jagiellonian University
- Investigators
- Radoslaw Pach, Ph.D., Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943419
- Sponsor's protocol ID
- Colorectal MDSC
- Status last verified
- Jul 2022
- First submitted
- 21 Jun 2021
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35650461
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloid-derived Suppressor Cells in Colorectal Cancer: Influence on Postoperative Complications and Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT04943419
- Acronym / sponsor ID
- Colorectal MDSC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer | – | Diagnostic Test: Level of Myeloid-Derived Suppressor CellsPatients with colorectal cancer qualified for elective operations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically-confirmed colorectal cancer who undergo elective surgery.
Key inclusion criteria (4 listed)
- age ≥ 18
- colorectal cancer confirmed by histological examination of biopsy specimen
- elective operation
- signed informed consent
Key exclusion criteria (4 listed)
- Age < 18
- Pregnancy or lactation
- Emergency operation
- General condition that precludes understanding and signing of the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Level of Myeloid-Derived Suppressor CellsEstablishing of levels of all MDSC, PMNMDSC, MMDSC, EMDSC, M/PMN MDSC ratio on the day before operation. | Diagnostic test | Colorectal cancer |
Primary outcome
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
6 secondary outcomes
Level of MDSC in patients with severe postoperative complications
Time frame: 30 days
Level of MDSC in patients with severe septic postoperative complications
Time frame: 30 days
Level of MDSC in patients after neoadjuvant therapy
Time frame: 1 day before surgery
Level of MDSC in patients with T2-T4 tumours after neoadjuvant treatment
Time frame: 1 day before surgery
Level of MDSC measured in the specimen
Time frame: 1 day
Level of MDSC in patients with left and right sided tumours
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Results publication: PubMed 35650461Rogala 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.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radoslaw Pach, Ph.D. principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Suppression, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of MDSC in patients with postoperative complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.