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

November 2, 2019 updated by: Tomasz Sawicki, University of Warmia and Mazury in Olsztyn

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Olsztyn, Poland, 10-561
        • Recruiting
        • Provincial Specialist Hospital in Olsztyn
        • Contact:
        • Principal Investigator:
          • Katarzyna Przybyłowicz, Prof
        • Principal Investigator:
          • Łukasz Zielonka, Prof
        • Principal Investigator:
          • Magdalena Gajęcka, Prof
        • Principal Investigator:
          • Tomasz Arłukowicz, MD, PhD
        • Principal Investigator:
          • Tomasz Sawicki, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the concentration of the mycotoxin
Time Frame: 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)
5 month
Characteristics of gut bacterial
Time Frame: 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.
6 month
Determination of anthropometric data
Time Frame: 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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warmia and Mazury in Olsztyn

Collaborators

Provincial Specialist Hospital in Olsztyn
Ministry of Health Republic of Poland

Investigators

  • Principal Investigator: Tomasz Sawicki, PhD, Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

November 2, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Cancer, Somatic (Diagnosis)

Clinical Trials on questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe