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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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