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

NCT ID: NCT04152265

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-12-31

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.

Detailed Description

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Conditions

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Colorectal Cancer, Somatic (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

questionnaires

Intervention Type OTHER

complete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF)

demographic data collections

Intervention Type OTHER

completing the demographic questionnaire

anthropometric data collections

Intervention Type OTHER

For the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany)

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.

Group Type EXPERIMENTAL

colonoscopy

Intervention Type PROCEDURE

colonoscopy

Collecte the biological samples

Intervention Type PROCEDURE

blood and faeces collections

Interventions

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colonoscopy

colonoscopy

Intervention Type PROCEDURE

questionnaires

complete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF)

Intervention Type OTHER

demographic data collections

completing the demographic questionnaire

Intervention Type OTHER

anthropometric data collections

For the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany)

Intervention Type OTHER

Collecte the biological samples

blood and faeces collections

Intervention Type PROCEDURE

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Provincial Specialist Hospital in Olsztyn

UNKNOWN

Sponsor Role collaborator

Ministry of Health Republic of Poland

UNKNOWN

Sponsor Role collaborator

University of Warmia and Mazury in Olsztyn

OTHER

Sponsor Role lead

Responsible Party

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Tomasz Sawicki

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomasz Sawicki, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury

Locations

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Provincial Specialist Hospital in Olsztyn

Olsztyn, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Tomasz Sawicki, PhD

Role: CONTACT

+48 89 524 55 19

Katarzyna Przybyłowicz, Prof

Role: CONTACT

+48 89 524 55 21

Facility Contacts

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Tomasz Arłukowicz, MD, PhD

Role: primary

+48 89 53 86 557

Other Identifiers

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6/2019

Identifier Type: -

Identifier Source: org_study_id

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