Possible Association of Intestinal Helminths and Protozoa With Colorectal Cancer Pathogenesis

March 1, 2023 updated by: Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Intestinal Helminths and Protozoan Infections in Patients With Colorectal Cancer: Prevalence and Possible Association With Cancer Pathogenesis

Colorectal cancer (CRC) has the third highest cancer incidence in the world. There is mounting evidence that the intestinal microbiota plays an important role in colorectal carcinogenesis. but there is no information on protozoa of intestinal microbiota except Blastocystis hominis, although data on this issue is scarce. In this study we are going to evaluate the prevalence of intestinal helminthes and protozoa in CRC patients and control group that includes random residents. Patients will be examined before, after surgery and chemotherapy. Parasites and protozoan infection intensity will be estimated by triple coproscopy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted on the basis of Research Institute of Epidemiology, Microbiology and Infectious Diseases and Research Center of Oncology, Ministry of Public Health of the Republic of Uzbekistan.

All the CRC patients from Research Center of Oncology will be examined with their written concent. Diagnosis of CRC is based on the results of clinical examination, endoscopic, histological, X-ray and laboratory data according to International Classification proposed by the American Joint Committee on Cancer (AJCC) with application TNM (T-tumor, N-nodus, M-metastases) for diagnosis. Descriptors in T (primary tumor) mean the degree of the tumor spreading in layers of the intestine; descriptors in N mean absence of metastases or the number of lymph nodes with metastases; descriptors in M shows absence or presence of remote metastases.

The control group will be a random residents of Tashkent city without any complaints from gastrointestinal tract matched by gender and age to the patients with CRC. Age of individuals under examination will be taken at the range from 17 to 90 years old.

Collection of stool samples Three stool samples for parasitological examination will be taken from both control subjects and CRC patients at 1-2 days interval. Stool samples were collected in individual containers, containing 5 ml of Turdiev's preservative provided conservation and staining of protozoa cysts and eggs of worms for a year. The Turdiev's preservative includes:80 ml of 0.2% aqueous solution of sodium nitrite, 10 ml of formaldehyde, 2 ml of glycerin, 8 ml of Lugol's solution, 250 ml of distilled water.

Collection of material for C. parvum (Cryptosporidium parvum) detection in stool samples will be carried out by preparation of fresh feces thin smears.

Stool samples examination Parasitological diagnosis will be performed by triple coproscopy using formalin - ethyl acetate concentration technique. For preparations staining Lugol's solution was used. The intensity of protozoa will be estimated by the number of protozoa in the field of view (ocular x10, objective x40), the number of protozoa will be calculated at least in 10 fields of view. 1-2, 3-4 and 5-6 microorganisms in a field of view were considered as infection of low, mean and high intensity respectively.

Modified Ziehl- Neelsen method will be used for staining and detection of C. parvum preparations. The stained smears will be observed with ×100 oil immersion lens for the presence of C. parvum.

Parasitological examination of the additional group of the patients obtained chemotherapy will be carried out before and after surgery and complete course of chemotherapy.

Study Type

Observational

Enrollment (Anticipated)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with colorectal cancer hospitalized in Department of Coloproctology at Research Center of Oncology. Diagnosis of colorectal cancer is based on the results of clinical examination, endoscopic, histological, X-ray and laboratory data according to International Classification proposed by the American Joint Committee on Cancer (AJCC) with application TNM for diagnosis.

The control group will be a residents of Tashkent city without any complaints from gastrointestinal tract matched by gender and age to the patients with CRC.

Description

Inclusion Criteria:

  • All patients with colorectal cancer before, after surgery and chemotherapy.

For control group:

  • Includes all individuals that doesn't have any complaints from gastrointestinal tract

Exclusion Criteria:

  • Age before 18.
  • Patients with other gastrointestinal disorders
  • Patients with any chronic concomitant diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with colorectal cancer
Patients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center.
Diagnostic test: Parasitological examination
Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
Other Names:
  • Coproscopy
Population
The control group includes residents of Tashkent city without any complaints from gastrointestinal tract matched by gender and age to the patients with colorectal cancer.
Diagnostic test: Parasitological examination
Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
Other Names:
  • Coproscopy
Patients with CRC without metastases
Patients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center.
Diagnostic test: Parasitological examination
Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
Other Names:
  • Coproscopy
Patients with CRC with metastases
Patients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center.
Diagnostic test: Parasitological examination
Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
Other Names:
  • Coproscopy
Patients with CRC before operation
Patients hospitalized with colorectal cancer before operation at the Department of Coloproctology of Republican Oncology Research Center.
Diagnostic test: Parasitological examination
Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
Other Names:
  • Coproscopy
Patients with CRC after operation
Patients hospitalized with colorectal cancer after operation at the Department of Coloproctology of Republican Oncology Research Center.
Diagnostic test: Parasitological examination
Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
Other Names:
  • Coproscopy
Patients with CRC before chemotherapy
Patients hospitalized with colorectal cancer before operation and chemotherapy at the Department of Chemotherapy of Republican Oncology Research Center.
Diagnostic test: Parasitological examination
Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
Other Names:
  • Coproscopy
Patients with CRC after chemotherapy
Patients hospitalized with colorectal cancer after operation and chemotherapy at the Department of Chemotherapy of Republican Oncology Research Center.
Diagnostic test: Parasitological examination
Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
Other Names:
  • Coproscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of intestinal helminths in patients with colorectal cancer and association with cancerogenesis
Time Frame: from 2015 to 2018 years
In this study we expect to find intestinal helminths in patients with colorectal cancer and determine their role in the development of colorectal cancer
from 2015 to 2018 years
Prevalence of Lamblia intestinalis and Cryptosporidium parvum in patients with colorectal cancer and association with cancerogenesis
Time Frame: from 2015 to 2018 years
In this study we expect to find pathogenic protozoa in patients with colorectal cancer and determine their role in the development of colorectal cancer
from 2015 to 2018 years
Prevalence of intestinal protozoa (commensals) in patients with colorectal cancer and association with cancerogenesis
Time Frame: from 2015 to 2018 years
In this study we are going to determine their prevalence and role in the development of colorectal cancer
from 2015 to 2018 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADCC 15 21 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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