T Helper Cytokines in End Stage Colorectal Cancers

NCT04540146 | Completed DMC

• 1 other identifier: Colorectal cytokine
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Ascites; T cell; Flow-cytometry; Cytokine

Outcome Measures

Primary Outcomes (1)

• cytokine levels

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

  3 months

Study Arms (2)

Case

End Stage Colorectal Cancer patients with intraabdominal ascites

Diagnostic Test: Flow-Cytometric analysis

Control

Congestive heart failure and liver cirrhosis patient who had intraabdominal ascites

Diagnostic Test: Flow-Cytometric analysis

Interventions

Flow-Cytometric analysis DIAGNOSTIC_TEST

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

Case; Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The end stage colorectal cancer patients with intraabdominal ascites will be the case group. Also congestive heart failure and liver cirrhosis patients with intraabdominal ascites will be the control group

You may qualify if:

• End stage Colorectal Cancer patients

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Ufuk Oguz Idiz

Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (3)

• Syed Khaja AS, Toor SM, El Salhat H, Ali BR, Elkord E. Intratumoral FoxP3+Helios+ Regulatory T Cells Upregulating Immunosuppressive Molecules Are Expanded in Human Colorectal Cancer. Front Immunol. 2017 May 26;8:619. doi: 10.3389/fimmu.2017.00619. eCollection 2017.

  PMID: 28603527 BACKGROUND

• Yoshida N, Kinugasa T, Miyoshi H, Sato K, Yuge K, Ohchi T, Fujino S, Shiraiwa S, Katagiri M, Akagi Y, Ohshima K. A High RORgammaT/CD3 Ratio is a Strong Prognostic Factor for Postoperative Survival in Advanced Colorectal Cancer: Analysis of Helper T Cell Lymphocytes (Th1, Th2, Th17 and Regulatory T Cells). Ann Surg Oncol. 2016 Mar;23(3):919-27. doi: 10.1245/s10434-015-4923-3. Epub 2015 Nov 12.

  PMID: 26564244 BACKGROUND

• Nakano M, Ito M, Tanaka R, Yamaguchi K, Ariyama H, Mitsugi K, Yoshihiro T, Ohmura H, Tsuruta N, Hanamura F, Sagara K, Okumura Y, Nio K, Tsuchihashi K, Arita S, Kusaba H, Akashi K, Baba E. PD-1+ TIM-3+ T cells in malignant ascites predict prognosis of gastrointestinal cancer. Cancer Sci. 2018 Sep;109(9):2986-2992. doi: 10.1111/cas.13723.

  PMID: 30187676 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Ascites

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ufuk Oguz Idiz, Assoc.Prof.

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 7, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 15, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

TU (1)