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

Not Applicable

• Conditions: Colorectal Cancer, Somatic (Diagnosis)
• Interventions: Other: questionnaires; Procedure: colonoscopy; Procedure: Collecte the biological samples; Other: demographic data collections; Other: anthropometric data collections

• Registration Number: NCT04152265
• Lead Sponsor: University of Warmia and Mazury in Olsztyn

Brief 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).

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-28
• Status Verified: 2019-11
• Study Start: 2019-11-01
• Study First Submitted QC: 2019-11-02
• Last Update Submitted: 2019-11-02
• Study First Posted: 2019-11-05
• Last Update Posted: 2019-11-05
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Intervention: Current screening practice.	questionnaires	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
Experimental: Sequential screening strategy	Collecte the biological samples	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.
No Intervention: Current screening practice.	anthropometric data collections	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
No Intervention: Current screening practice.	demographic data collections	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
Experimental: Sequential screening strategy	colonoscopy	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.

Primary Outcome Measures

Name	Time	Method
Completion of the assigned screening strategy	Within 8 weeks of enrollment	Completion of the assigned screening strategy within 8 weeks of enrollment defined as: \* current screening strategy: documented screening colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Analysis of the concentration of the mycotoxin	5 month	Determination of the concentration and a profile of the mycotoxin using the high-performance liquid chromatography coupled with the mass spectrometry (HPLC-MS)
Characteristics of gut bacterial	6 month	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.
Determination of anthropometric data	4 weeks	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

Trial Locations

Locations (1)

Provincial Specialist Hospital in Olsztyn; 🇵🇱 Olsztyn, Poland