The Status of Immune Checkpoints at Gastrointestinal Cancer

NCT04566848 | Completed

• 1 other identifier: Gastrointestinal checkpoints
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancers are the third most common cancer in the world. In advanced stages of colorectal cancers, peritoneal carcinomatosis and intraabdominal acid development occur. Although stomach cancer is the 5th most common cancer in the world, it is the third cancer with the highest mortality. Pancreatic cancer is one of the highest mortality cancers worldwide. Likewise, in advanced stages of stomach and pancreatic cancer, peritoneal carcinomatosis and intra- abdominal acid development occur. It is known that the immune system plays an important role in tumor development or destruction of tumor. Recent studies have shown that tumor cells develop escape mechanisms in the tumor microenvironment to escape from host immunity. It has been reported that differentiation of T cells towards Th2 and regulatory T cells is also effective in tumor progression(6). Changes in the tumor microenvironment and immune checkpoints are important mechanisms that lead to escape from the immune system. Immune checkpoints are on the agenda especially after 2018 Nobel Prize and they are important molecules in revealing the relationship.In our study, it is aimed to evaluate whether there is a difference in immune control points in patients with end-stage colorectal cancer, gastric cancer and pancreatic cancer compared to patients without malignancy, and the relationship of these parameters with patient survival and tumor spread mechanisms.

Conditions

Gastrointestinal Cancer

Keywords

Pancreatic cancer; Gastric cancer; Colorectal Cancer; Immune checkpoints

Outcome Measures

Primary Outcomes (1)

• Immune Checkpoints

  sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9

  4 months

Study Arms (2)

Gastrointestinal cancers

Patients with advanced stage colorectal cancer, gastric cancer and pancreatic cancer who develop malignant ascites

Diagnostic Test: Flow cytometric analysis

Control

Patients with intraabdominal ascites with benign reasons (liver cirrhosis, Congestive heart failure, etc.) .

Diagnostic Test: Flow cytometric analysis

Interventions

Flow cytometric analysis DIAGNOSTIC_TEST

Measuring the sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9 levels with flow cytometry

Control; Gastrointestinal cancers

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intraabdominal ascites with benign reasons (liver cirrhosis, Congestive heart failure, etc.) will be the control group, and patients with advanced stage colorectal cancer, gastric cancer and pancreatic cancer who develop malignant ascites will be the gastrointestinal cancer group

You may qualify if:

• Patients with intraabdominal ascites with benign reasons (liver cirrhosis, Congestive heart failure, etc.) for control group
• Patients with advanced stage colorectal cancer, gastric cancer and pancreatic cancer who develop malignant ascites for gastrointestinal cancer group

You may not qualify if:

• Pregnant
• Primary immune system failure
• HIV patients

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead
• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: collaborator

Study Sites (1)

Istanbul Training and Reseach Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

• Sasidharan Nair V, Toor SM, Taha RZ, Shaath H, Elkord E. DNA methylation and repressive histones in the promoters of PD-1, CTLA-4, TIM-3, LAG-3, TIGIT, PD-L1, and galectin-9 genes in human colorectal cancer. Clin Epigenetics. 2018 Aug 6;10(1):104. doi: 10.1186/s13148-018-0539-3.

  PMID: 30081950 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

• Keir ME, Butte MJ, Freeman GJ, Sharpe AH. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol. 2008;26:677-704. doi: 10.1146/annurev.immunol.26.021607.090331.

  PMID: 18173375 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ufuk Oguz Idiz, Assoc. Prof. MD.

  İstanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Eyup Kaya, MD

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: August 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-03

Locations

TU (1)