Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population

Study Overview
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Brief Summary
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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.

Official Title
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Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population

Conditions
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Colorectal Cancer, Somatic (Diagnosis)

Intervention / Treatment
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* Procedure: colonoscopy
* Other: questionnaires
* Other: demographic data collections
* Other: anthropometric data collections
* Procedure: Collecte the biological samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged from 50 to 65 years residing in Poland. Exclusion Criteria: subjects requiring long-term care due to somatic, mental retardation or other mental illness. history of colorectal resection.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No Intervention: Current screening practice.<br>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 | Other: questionnaires<br>* complete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF)<br>Other: demographic data collections<br>* completing the demographic questionnaire<br>Other: anthropometric data collections<br>* For the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany)<br>|
| Experimental: Experimental: Sequential screening strategy<br>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. | Procedure: colonoscopy<br>* colonoscopy<br>Procedure: Collecte the biological samples<br>* blood and faeces collections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 8 weeks of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 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 | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, zearalenone, mycotoxin, gastrointestinal bacterial