Colorectal Cancer, Somatic (Diagnosis)NCT04152265
Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population
A study testing colonoscopy, questionnaires and demographic data collections in people with Colorectal Cancer, Somatic (Diagnosis), run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
Trial summary
The aim of the study is the determination of the zearalenone and its metabolites (α and β) level in the blood plasma and faeces of patients at increased risk of cancer, in relation to the nutrition data (FFQ) and information on the quality of life dependent on health (WHOQOL-BREF). Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Somatic (Diagnosis)
- What is being tested?
- colonoscopy, questionnaires and demographic data collections
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2019to 31 Dec 2020
- Phase
- Interventional
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged from 50 to 65 years residing in Poland.
Who cannot join
- subjects requiring long-term care due to somatic, mental retardation or other mental illness.
- history of colorectal resection.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Provincial Specialist Hospital in Olsztyn
Olsztyn, 10-561
Tomasz Arłukowicz, MD, PhD, +48 89 53 86 557, tarlukowicz@wss.olsztyn.pl
Katarzyna Przybyłowicz, Prof
About this study
The aim of the study is the determination of the zearalenone and its metabolites (α and β) level in the blood plasma and faeces of patients at increased risk of cancer, in relation to the nutrition data (FFQ) and information on the quality of life dependent on health (WHOQOL-BREF).
The study is performer within the framework of the Polish Colonoscopy Screening Program. Within the study 100 volunteers between 50 and 65 years of age. while, the colonoscopies will be performed in Provincial Specialist Hospital in Olsztyn. Patients with positive test result, who have been diagnosed with polyps or cancer, will be assigned to risk group. The study has been approved by a local bioethics committee.
- Conditions
- Colorectal Cancer, Somatic (Diagnosis)
- Being tested
- colonoscopy, questionnaires, demographic data collections, anthropometric data collections, Collecte the biological samples
- Keywords
- colorectal cancer, zearalenone, mycotoxin, gastrointestinal bacterial
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
colonoscopy
questionnairesOther
complete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF)
demographic data collectionsOther
completing the demographic questionnaire
anthropometric data collectionsOther
For the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany)
Collecte the biological samplesProcedure or surgery
blood and faeces collections
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Current screening practice. | Other | Patients will be asked to complete the Food Frequency Questionnaire (FFQ) and the questionnaire about The World Health Organization Quality Of Life (WHOQOL-BREF), also and will be collected the demographic and anthropometric data Receives: Other: questionnaires; Other: demographic data collections; Other: anthropometric data collections |
| Experimental: Sequential screening strategy | Experimental | People aged between 50-65, will take part in the study. Patients, which will take in a screening colonoscopy, will be divided into two groups according to the result obtained. The first group, will be constitute the patients with a positive test result, while the second group (control) will be constitute the patients with the negative test result. In addition, from the Subjects the samples of blood and faeces will be collected. Receives: Procedure: colonoscopy; Procedure: Collecte the biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the assigned screening strategy
Completion of the assigned screening strategy within 8 weeks of enrollment defined as:
- current screening strategy: documented screening colonoscopy.
Measured: Within 8 weeks of enrollment
Secondary outcomes (3)
Analysis of the concentration of the mycotoxin
Determination of the concentration and a profile of the mycotoxin using the high-performance liquid chromatography coupled with the mass spectrometry (HPLC-MS)
Measured: 5 month
Characteristics of gut bacterial
The presence of bacterial DNA in the samples will be confirmed using real-time polymerase chain reaction (RT-PCR). Microbial diversity will be study by sequencing the amplified V3-V4 region of the 16S rRNA gene by using primers 16S. Next, the amplicon pools will be prepared for sequencing and the size and quantity of the amplicon library will be assessed on NGS MiSeq.
Measured: 6 month
Determination of anthropometric data
The anthropometric data will be determined using the professional body mass composition analyser. Based on the obtained data will be calculated Body Mass Index (BMI), which will be expressed in kg/m^2
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Nov 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer, Somatic (Diagnosis)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury in Olsztyn
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Specialist Hospital in Olsztyn, Ministry of Health, Poland
- Responsible party
- Principal investigator, Tomasz Sawicki, University of Warmia and Mazury in Olsztyn
- Investigators
- Tomasz Sawicki, PhD, Principal investigator, Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152265
- Sponsor's protocol ID
- 6/2019
- Status last verified
- Nov 2019
- First submitted
- 28 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population
- ClinicalTrials.gov ID
- NCT04152265
- Acronym / sponsor ID
- 6/2019
- Conditions
- Colorectal Cancer, Somatic (Diagnosis)
- Keywords
- colorectal cancer, zearalenone, mycotoxin, gastrointestinal bacterial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Warmia and Mazury in OlsztynUniversity, hospital or other
- Collaborators
- Provincial Specialist Hospital in Olsztyn, Ministry of Health, Poland
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Nov 2019 (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.
The aim of the study is the determination of the zearalenone and its metabolites (α and β) level in the blood plasma and faeces of patients at increased risk of cancer, in relation to the nutrition data (FFQ) and information on the quality of life dependent on health (WHOQOL-BREF).
The study is performer within the framework of the Polish Colonoscopy Screening Program. Within the study 100 volunteers between 50 and 65 years of age. while, the colonoscopies will be performed in Provincial Specialist Hospital in Olsztyn. Patients with positive test result, who have been diagnosed with polyps or cancer, will be assigned to risk group. The study has been approved by a local bioethics committee.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Current screening practice. | Other | Other: questionnaires, Other: demographic data collections, Other: anthropometric data collectionsPatients will be asked to complete the Food Frequency Questionnaire (FFQ) and the questionnaire about The World Health Organization Quality Of Life (WHOQOL-BREF), also and will be collected the demographic and anthropometric data |
| Experimental: Sequential screening strategy | Experimental | Procedure: colonoscopy, Procedure: Collecte the biological samplesPeople aged between 50-65, will take part in the study. Patients, which will take in a screening colonoscopy, will be divided into two groups according to the result obtained. The first group, will be constitute the patients with a positive test result, while the second group (control) will be constitute the patients with the negative test result. In addition, from the Subjects the samples of blood and faeces will be collected. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged from 50 to 65 years residing in Poland.
Key exclusion criteria (2 listed)
- subjects requiring long-term care due to somatic, mental retardation or other mental illness.
- history of colorectal resection.
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 |
|---|---|---|
| colonoscopycolonoscopy | Procedure or surgery | Experimental: Sequential screening strategy |
| questionnairescomplete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF) | Other | No Intervention: Current screening practice. |
| demographic data collectionscompleting the demographic questionnaire | Other | No Intervention: Current screening practice. |
| anthropometric data collectionsFor the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany) | Other | No Intervention: Current screening practice. |
| Collecte the biological samplesblood and faeces collections | Procedure or surgery | Experimental: Sequential screening strategy |
Primary outcome
Completion of the assigned screening strategy
Time frame: Within 8 weeks of enrollment
Completion of the assigned screening strategy within 8 weeks of enrollment defined as: * current screening strategy: documented screening colonoscopy.
3 secondary outcomes
Analysis of the concentration of the mycotoxin
Time frame: 5 month
Characteristics of gut bacterial
Time frame: 6 month
Determination of anthropometric data
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
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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.
Tomasz Sawicki, PhD principal investigator
Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy, questionnaires and demographic data collections in people with Colorectal Cancer, Somatic (Diagnosis), run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
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 1 inclusion and 2 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Tomasz Sawicki, PhD (+48 89 524 55 19, tomasz.sawicki@uwm.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of the assigned screening strategy (time frame: Within 8 weeks of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2019.