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Clinical Trials/NCT04540146
NCT04540146
Completed
Not Applicable

Evaluation of T Helper Cytokines in Intraabdominal Ascites in End Stage Colorectal Cancers

Istanbul Training and Research Hospital1 site in 1 country40 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Istanbul Training and Research Hospital
Enrollment
40
Locations
1
Primary Endpoint
cytokine levels
Status
Completed
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
December 15, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istanbul Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ufuk Oguz Idiz

Assoc. Prof. MD

Istanbul Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • End stage Colorectal Cancer patients

Exclusion Criteria

  • Another synchronous tumor with colorectal cancer
  • HIV patients
  • Pregnancy

Outcomes

Primary Outcomes

cytokine levels

Time Frame: 3 months

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

Study Sites (1)

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