Colorectal Cancer, Somatic (Diagnosis) Clinical Trial
Official title:
Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Prevention and Development Among Polish Population
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 50 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Provincial Specialist Hospital in Olsztyn | Olsztyn |
| Lead Sponsor | Collaborator |
|---|---|
| University of Warmia and Mazury in Olsztyn | Ministry of Health Republic of Poland, Provincial Specialist Hospital in Olsztyn |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Characteristics of gut bacterial | 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 | |
| Secondary | 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 |