NCT04540159

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. Among the mechanisms of escape from the immune system, changes in the tumor microenvironment play an important role. Immune checkpoints are molecules that have become popular especially after the Nobel Prize in 2018, and are important in revealing the relationship between cancer and the immune system. In our study, it is aimed to evaluate whether there is a difference in intraabdominal ascites fluid immune checkpoints level in patients with advanced colorectal cancer patients compared to patients without malignancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

September 4, 2020

Last Update Submit

December 4, 2022

Conditions

Colorectal Cancer

Keywords

AscitesImmune checkpointsFlow-cytometry

Outcome Measures

Primary Outcomes (1)

  • Immune Checkpoint levels

    Measuring the level of sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9 in the intraabdominal ascites

    4 months

Study Arms (2)

Case

Advanced stage Colorectal cancer patients with intraabdominal ascites

Diagnostic Test: Flow-cytometric analysis

Control

Liver cirrhosis and congestive heart failure patients with intraabdominal ascites

Diagnostic Test: Flow-cytometric analysis

Interventions

Flow-cytometric analysisDIAGNOSTIC_TEST

Measuring the level of sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9 in the intraabdominal ascites

CaseControl

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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You may qualify if:

  • Advanced stage colorectal cancer patients with intraabdominal ascites

You may not qualify if:

  • Patients who have cancer other than colorectal cancer
  • Patients with peritonitis
  • Pregnant women
  • HIV (+) patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk Oguz Idiz

Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 30187676BACKGROUND

  • Radestad E, Klynning C, Stikvoort A, Mogensen O, Nava S, Magalhaes I, Uhlin M. Immune profiling and identification of prognostic immune-related risk factors in human ovarian cancer. Oncoimmunology. 2018 Nov 16;8(2):e1535730. doi: 10.1080/2162402X.2018.1535730. eCollection 2019.

    PMID: 30713791BACKGROUND

  • 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: 26564244BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsAscites

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological 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

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Locations

TU(1)