Colorectal CancerNCT03173001
Possible Association of Intestinal Helminths and Protozoa With Colorectal Cancer Pathogenesis
An observational study of Colorectal Cancer and Colorectal Cancer Metastatic, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Cancer Metastatic, Intestinal Parasite
- What is being tested?
- Parasitological examination
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age before 18.
- Patients with other gastrointestinal disorders
- Patients with any chronic concomitant diseases
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Colorectal Cancer Metastatic, Intestinal Parasite, Protozoan Infections
- Being tested
- Parasitological examination
- Keywords
- intestinal helminths; protozoan infections;, colorectal cancer; chemotherapy; cancer pathogenesis;
- Medical subject headings
- Colorectal Neoplasms, Intestinal Diseases, Parasitic, Protozoan Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasitological examinationDiagnostic test
Also called Coproscopy
Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal cancer | Patients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center. Receives: 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. Receives: Diagnostic Test: Parasitological examination | |
| Patients with CRC without metastases | Patients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center. Receives: Diagnostic Test: Parasitological examination | |
| Patients with CRC with metastases | Patients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Parasitological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: from 2015 to 2018 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Jan 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173001
- Sponsor's protocol ID
- ADCC 15 21 2
- Status last verified
- Mar 2023
- First submitted
- 29 May 2017
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30220046
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Helminths and Protozoan Infections in Patients With Colorectal Cancer: Prevalence and Possible Association With Cancer Pathogenesis
- ClinicalTrials.gov ID
- NCT03173001
- Acronym / sponsor ID
- ADCC 15 21 2
- Conditions
- Colorectal Cancer, Colorectal Cancer Metastatic, Intestinal Parasite, Protozoan Infections
- Keywords
- intestinal helminths; protozoan infections;, colorectal cancer; chemotherapy; cancer pathogenesis;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, UzbekistanOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal cancer | – | Diagnostic Test: Parasitological examinationPatients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center. |
| Population | – | Diagnostic Test: Parasitological examinationThe control group includes residents of Tashkent city without any complaints from gastrointestinal tract matched by gender and age to the patients with colorectal cancer. |
| Patients with CRC without metastases | – | Diagnostic Test: Parasitological examinationPatients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center. |
| Patients with CRC with metastases | – | Diagnostic Test: Parasitological examinationPatients hospitalized with colorectal cancer at the Department of Coloproctology of Republican Oncology Research Center. |
| Patients with CRC before operation | – | Diagnostic Test: Parasitological examinationPatients hospitalized with colorectal cancer before operation at the Department of Coloproctology of Republican Oncology Research Center. |
| Patients with CRC after operation | – | Diagnostic Test: Parasitological examinationPatients hospitalized with colorectal cancer after operation at the Department of Coloproctology of Republican Oncology Research Center. |
| Patients with CRC before chemotherapy | – | Diagnostic Test: Parasitological examinationPatients hospitalized with colorectal cancer before operation and chemotherapy at the Department of Chemotherapy of Republican Oncology Research Center. |
| Patients with CRC after chemotherapy | – | Diagnostic Test: Parasitological examinationPatients hospitalized with colorectal cancer after operation and chemotherapy at the Department of Chemotherapy of Republican Oncology Research Center. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- All patients with colorectal cancer before, after surgery and chemotherapy.
- Includes all individuals that doesn't have any complaints from gastrointestinal tract
Key exclusion criteria (3 listed)
- Age before 18.
- Patients with other gastrointestinal disorders
- Patients with any chronic concomitant diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasitological examinationAlso: CoproscopyThree stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval. | Diagnostic test | Patients with CRC after chemotherapy, Patients with CRC after operation, Patients with CRC before chemotherapy, Patients with CRC before operation, Patients with CRC with metastases, Patients with CRC without metastases, Patients with colorectal cancer, Population |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Results publication: PubMed 30220046Toychiev 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Cancer Metastatic, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of intestinal helminths in patients with colorectal cancer and association with cancerogenesis (time frame: from 2015 to 2018 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.