T Helper Cytokines in End Stage Colorectal Cancers

Sponsor
Istanbul Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04540146
Collaborator
(none)
40
1
4.5
9

Study Details

Study Description

Brief Summary

Colorectal cancers are the third most common type of cancer in the world. Peritoneal carcinomatosis and intraabdominal acid development occur in advanced stages of colorectal cancers.

It is known that the immune system plays an important role in tumor development or tumor eradication. Differentiation of T cells towards Th2 and regulatory T cells is also reported to be effective in tumor progression.

Among the mechanisms of escape from the immune system, changes in the tumor microenvironment play an important role. The role of regulatory T lymphocytes, a subgroup of T cells that play a regulatory role by suppressing the function of other T lymphocytes, is to reduce the chronic immune response against viruses, tumors and patients's own antigens. The common feature of all Tregs is that they secrete one or more anti-inflammatory molecules such as IL-10, TGFβ or IL-35. High levels of Tregs have been found in peripheral blood, tumor tissue and lymph nodes in patients with malignancy.

In our study, it is aimed to evaluate whether there is a difference in intraabdominal ascites fluid T helper cytokine levels in patients with end-stage colorectal cancers compared to patients without malignancy.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Flow-Cytometric analysis

Detailed Description

Colorectal cancers are the third most common type of cancer in the world. Peritoneal carcinomatosis and intraabdominal ascites development occur in advanced stages of colorectal cancers.

It is known that the immune system plays an important role in tumor development or tumor eradication. Differentiation of T cells towards Th2 and regulatory T cells is also reported to be effective in tumor progression.

Among the mechanisms of escape from the immune system, changes in the tumor microenvironment play an important role. The role of regulatory T lymphocytes, a subgroup of T cells that play a regulatory role by suppressing the function of other T lymphocytes, is to reduce the chronic immune response against viruses, tumors and patient's own antigens. The common feature of all Tregs is that they secrete one or more anti-inflammatory molecules such as IL-10, TGFβ or IL-35. High levels of Tregs have been found in peripheral blood, tumor tissue and lymph nodes in patients with malignancy.

The role of the immune system in colorectal cancers has been demonstrated with the effects of tumor-infiltrating lymphocytes (TIL) and immune control points on TILs or immune control point ligands on patient survival, especially in recent studies. Studies in the literature usually include immunological examinations of patient blood or tumor tissue.

There are many publications in the literature evaluating immunological markers from ascites fluid samples for various reasons. In these studies, T and B cell subtypes were examined from ascites fluid samples taken from patients with ascites, especially ovarian cancer and liver cirrhosis. In the only study on gastrointestinal cancers, immunophenotyping was performed in intraabdominal ascites and blood in 22 advanced gastrointestinal tumor patients and some cell subgroups were associated with worse clinical outcome. In the literature, there is no study on cytokine analysis from intra-abdominal ascites fluids specific to colorectal cancer.

In our study, it is aimed to evaluate whether there is a difference in intraabdominal ascites fluid cytokine level in patients with end-stage colorectal patients compared to patients without malignancy.

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of T Helper Cytokines in Intraabdominal Ascites in End Stage Colorectal Cancers
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Case

End Stage Colorectal Cancer patients with intraabdominal ascites

Diagnostic Test: Flow-Cytometric analysis
IL-2, 4, 5, 6, 9, 10, 13, 17A, 17F, 22, IFN-γ and TNF-α levels in the intraabdominal ascites

Control

Congestive heart failure and liver cirrhosis patient who had intraabdominal ascites

Diagnostic Test: Flow-Cytometric analysis
IL-2, 4, 5, 6, 9, 10, 13, 17A, 17F, 22, IFN-γ and TNF-α levels in the intraabdominal ascites

Outcome Measures

Primary Outcome Measures

  1. cytokine levels [3 months]

    IL-2, 4, 5, 6, 9, 10, 13, 17A, 17F, 22, IFN-γ and TNF-α levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • End stage Colorectal Cancer patients
Exclusion Criteria:
  • Another synchronous tumor with colorectal cancer

  • HIV patients

  • Pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ufuk Oguz Idiz Istanbul Turkey 34371

Sponsors and Collaborators

  • Istanbul Training and Research Hospital

Investigators

  • Principal Investigator: Ufuk Oguz Idiz, Assoc.Prof., Istanbul Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ufuk Oguz Idiz, Assoc. Prof. MD, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04540146
Other Study ID Numbers:
  • Colorectal cytokine
First Posted:
Sep 7, 2020
Last Update Posted:
Jul 27, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ufuk Oguz Idiz, Assoc. Prof. MD, Istanbul Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2021