Colorectal Cancer, Somatic (Diagnosis)
Conditions
Keywords
colorectal cancer, zearalenone, mycotoxin, gastrointestinal bacterial
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.
Interventions
PROCEDUREcolonoscopy
colonoscopy
OTHERquestionnaires
complete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF)
OTHERdemographic data collections
completing the demographic questionnaire
OTHERanthropometric data collections
For the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany)
PROCEDURECollecte the biological samples
blood and faeces collections
Sponsors
Provincial Specialist Hospital in Olsztyn
Ministry of Health Republic of Poland
University of Warmia and Mazury in Olsztyn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of the assigned screening strategy | Within 8 weeks of enrollment | Completion of the assigned screening strategy within 8 weeks of enrollment defined as: \* current screening strategy: documented screening colonoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of the concentration of the mycotoxin | 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) |
| Characteristics of gut bacterial | 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. |
| Determination of anthropometric data | 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 |
Countries
Poland
Contacts
Primary ContactTomasz Sawicki, PhD
Backup ContactKatarzyna Przybyłowicz, Prof
Outcome results
None listed