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

University of Warmia and Mazury in Olsztyn

Status: Unknown

Conditions: Colorectal Cancer, Somatic (Diagnosis)

Treatments: Procedure: colonoscopy; Other: anthropometric data collections; Other: questionnaires; Other: demographic data collections; Procedure: Collecte the biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04152265

6/2019

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

No Intervention: Current screening practice.

Other group

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

Treatment:

Other: demographic data collections

Other: questionnaires

Other: anthropometric data collections

Experimental: Sequential screening strategy

Experimental group

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.

Treatment:

Procedure: Collecte the biological samples

Procedure: colonoscopy