NCT03173001

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
unknown

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

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

11 years

First QC Date

May 29, 2017

Last Update Submit

March 1, 2023

Conditions

Keywords

intestinal helminths; protozoan infections;colorectal cancer; chemotherapy; cancer pathogenesis;

Outcome Measures

Primary Outcomes (3)

  • Prevalence of intestinal helminths in patients with colorectal cancer and association with cancerogenesis

    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

    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

    In this study we are going to determine their prevalence and role in the development of colorectal cancer

    from 2015 to 2018 years

Study Arms (8)

Patients with colorectal cancer

Patients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center.

Diagnostic Test: Parasitological examination

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

Patients with CRC without metastases

Patients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center.

Diagnostic Test: Parasitological examination

Patients with CRC with metastases

Patients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center.

Diagnostic Test: Parasitological examination

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

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

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

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

Interventions

Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.

Also known as: Coproscopy
Patients with CRC after chemotherapyPatients with CRC after operationPatients with CRC before chemotherapyPatients with CRC before operationPatients with CRC with metastasesPatients with CRC without metastasesPatients with colorectal cancerPopulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Toychiev A, Abdujapparov S, Imamov A, Navruzov B, Davis N, Badalova N, Osipova S. Intestinal helminths and protozoan infections in patients with colorectal cancer: prevalence and possible association with cancer pathogenesis. Parasitol Res. 2018 Dec;117(12):3715-3723. doi: 10.1007/s00436-018-6070-9. Epub 2018 Sep 15.

MeSH Terms

Conditions

Colorectal NeoplasmsIntestinal Diseases, ParasiticProtozoan Infections

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesParasitic DiseasesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 1, 2017

Study Start

January 1, 2015

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 3, 2023

Record last verified: 2023-03