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Trial record 20 of 4147 for:    colon cancer AND Intestinal Neoplasms

Possible Association of Intestinal Helminths and Protozoa With Colorectal Cancer Pathogenesis

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ClinicalTrials.gov Identifier: NCT03173001
Recruitment Status : Active, not recruiting
First Posted : June 1, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

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.

Condition or disease Intervention/treatment
Colorectal Cancer Colorectal Cancer Metastatic Intestinal Parasite Protozoan Infections Diagnostic Test: Parasitological examination

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Intestinal Helminths and Protozoan Infections in Patients With Colorectal Cancer: Prevalence and Possible Association With Cancer Pathogenesis
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Coproscopy




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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

Additional Information:

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Responsible Party: Svetlana Osipova, MD, PhD, DS, Professor, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
ClinicalTrials.gov Identifier: NCT03173001     History of Changes
Other Study ID Numbers: ADCC 15 21 2
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan:
intestinal helminths; protozoan infections;
colorectal cancer; chemotherapy; cancer pathogenesis;

Additional relevant MeSH terms:
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Intestinal Diseases, Parasitic
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Infection
Protozoan Infections
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Parasitic Diseases