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| Name | Class |
|---|---|
| Provincial Specialist Hospital in Olsztyn | UNKNOWN |
| Ministry of Health, Poland | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colonoscopy | Procedure | colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of the concentration of the mycotoxin | Determination of the concentration and a profile of the mycotoxin using the high-performance liquid chromatography coupled with the mass spectrometry (HPLC-MS) | 5 month |
| Characteristics of gut bacterial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Sawicki, PhD | Department of Human Nutrition, Faculty of Food Science, University of Warmia and Mazury | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Provincial Specialist Hospital in Olsztyn | Recruiting | Olsztyn | 10-561 | Poland |
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| questionnaires |
| 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 | Other | completing the demographic questionnaire |
|
| anthropometric data collections | Other | For the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany) |
|
| Collecte the biological samples | Procedure | blood and faeces collections |
|
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.
| 6 month |
| Determination of anthropometric data | 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 | 4 weeks |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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