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

Primary Purpose

Colorectal Cancer, Somatic (Diagnosis)

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
colonoscopy
questionnaires
demographic data collections
anthropometric data collections
Collecte the biological samples
Sponsored by
University of Warmia and Mazury in Olsztyn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer, Somatic (Diagnosis) focused on measuring colorectal cancer, zearalenone, mycotoxin, gastrointestinal bacterial

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Provincial Specialist Hospital in OlsztynRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

No Intervention: Current screening practice.

Experimental: Sequential screening strategy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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

Full Information

First Posted
October 28, 2019
Last Updated
November 2, 2019
Sponsor
University of Warmia and Mazury in Olsztyn
Collaborators
Provincial Specialist Hospital in Olsztyn, Ministry of Health Republic of Poland
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1. Study Identification

Unique Protocol Identification Number
NCT04152265
Brief Title
Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population
Official Title
Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Warmia and Mazury in Olsztyn
Collaborators
Provincial Specialist Hospital in Olsztyn, Ministry of Health Republic of Poland

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Somatic (Diagnosis)
Keywords
colorectal cancer, zearalenone, mycotoxin, gastrointestinal bacterial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Intervention: Current screening practice.
Arm Type
Other
Arm Description
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
Arm Title
Experimental: Sequential screening strategy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
colonoscopy
Intervention Description
colonoscopy
Intervention Type
Other
Intervention Name(s)
questionnaires
Intervention Description
complete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF)
Intervention Type
Other
Intervention Name(s)
demographic data collections
Intervention Description
completing the demographic questionnaire
Intervention Type
Other
Intervention Name(s)
anthropometric data collections
Intervention Description
For the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany)
Intervention Type
Procedure
Intervention Name(s)
Collecte the biological samples
Intervention Description
blood and faeces collections
Primary Outcome Measure Information:
Title
Completion of the assigned screening strategy
Description
Completion of the assigned screening strategy within 8 weeks of enrollment defined as: * current screening strategy: documented screening colonoscopy.
Time Frame
Within 8 weeks of enrollment
Secondary Outcome Measure Information:
Title
Analysis of the concentration of the mycotoxin
Description
Determination of the concentration and a profile of the mycotoxin using the high-performance liquid chromatography coupled with the mass spectrometry (HPLC-MS)
Time Frame
5 month
Title
Characteristics of gut bacterial
Description
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.
Time Frame
6 month
Title
Determination of anthropometric data
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Sawicki, PhD
Phone
+48 89 524 55 19
Email
tomasz.sawicki@uwm.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna Przybyłowicz, Prof
Phone
+48 89 524 55 21
Email
katarzyna.przybylowicz@uwm.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Sawicki, PhD
Organizational Affiliation
Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury
Official's Role
Principal Investigator
Facility Information:
Facility Name
Provincial Specialist Hospital in Olsztyn
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Arłukowicz, MD, PhD
Phone
+48 89 53 86 557
Email
tarlukowicz@wss.olsztyn.pl
First Name & Middle Initial & Last Name & Degree
Katarzyna Przybyłowicz, Prof
First Name & Middle Initial & Last Name & Degree
Łukasz Zielonka, Prof
First Name & Middle Initial & Last Name & Degree
Magdalena Gajęcka, Prof
First Name & Middle Initial & Last Name & Degree
Tomasz Arłukowicz, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tomasz Sawicki, PhD

12. IPD Sharing Statement

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

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