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

NCT04152265 | Unknown

• 1 other identifier: 6/2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer, Somatic (Diagnosis)

Keywords

colorectal cancer; zearalenone; mycotoxin; gastrointestinal bacterial

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 8 weeks of enrollment

Secondary Outcomes (3)

• Analysis of the concentration of the mycotoxin

  5 month

• Characteristics of gut bacterial

  6 month

• Determination of anthropometric data

  4 weeks

Study Arms (2)

No Intervention: Current screening practice.

OTHER

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; Other: demographic data collections; Other: anthropometric data collections

Experimental: Sequential screening strategy

EXPERIMENTAL

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; Procedure: Collecte the biological samples

Interventions

colonoscopy PROCEDURE

colonoscopy

Experimental: Sequential screening strategy

questionnaires OTHER

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

No Intervention: Current screening practice.

demographic data collections OTHER

completing the demographic questionnaire

No Intervention: Current screening practice.

anthropometric data collections OTHER

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

No Intervention: Current screening practice.

Collecte the biological samples PROCEDURE

blood and faeces collections

Experimental: Sequential screening strategy

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged from 50 to 65 years residing in Poland.

You may not qualify if:

• subjects requiring long-term care due to somatic, mental retardation or other mental illness.
• history of colorectal resection.

Sponsors & Collaborators

• University of Warmia and Mazury in Olsztyn: lead
• Provincial Specialist Hospital in Olsztyn: collaborator
• Ministry of Health Republic of Poland: collaborator

Study Sites (1)

Provincial Specialist Hospital in Olsztyn

Olsztyn, 10-561, Poland

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Disease

Interventions

Colonoscopy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tomasz Sawicki, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Sawicki, PhD

CONTACT

+48 89 524 55 19; tomasz.sawicki@uwm.edu.pl

Katarzyna Przybyłowicz, Prof

CONTACT

+48 89 524 55 21; katarzyna.przybylowicz@uwm.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 5, 2019
• Study Start: November 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

PL (1)