Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population
NCT ID: NCT04152265
Last Updated: 2019-11-05
Study Results
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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-11-01
2020-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
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
questionnaires
complete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF)
demographic data collections
completing the demographic questionnaire
anthropometric data collections
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.
colonoscopy
colonoscopy
Collecte the biological samples
blood and faeces collections
Interventions
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colonoscopy
colonoscopy
questionnaires
complete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF)
demographic data collections
completing the demographic questionnaire
anthropometric data collections
For the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany)
Collecte the biological samples
blood and faeces collections
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* history of colorectal resection.
50 Years
65 Years
ALL
Yes
Sponsors
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Provincial Specialist Hospital in Olsztyn
UNKNOWN
Ministry of Health Republic of Poland
UNKNOWN
University of Warmia and Mazury in Olsztyn
OTHER
Responsible Party
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Tomasz Sawicki
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6/2019
Identifier Type: -
Identifier Source: org_study_id
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