C18 C19 C20
Conditions
Interventions
Group 1: Other study, single-arm, with performance of colonoscopy (patients for screening, screening and diagnostic) to investigate the prevalence of colorectal neoplasia, including colorectal cancer,
Sponsors
Nationales Centrum für Tumorerkrankungen (NCT) und Deutsches Krebsforschungszentrum (DKFZ)
Eligibility
Sex/Gender
All
Age
30 Years to 49 Years
Inclusion criteria
Inclusion criteria: - Women or men - Age 30 to 49 at the day of invitation to the study - Main residence in Heidelberg, Mannheim and Rhine-Neckar-Kreis (as defined by community codes) - Ability to speak and understand German language - Ability to give legally binding informed consent
Exclusion criteria
Exclusion criteria: Participants will not be eligible for part II of the study if they - have a history of colorectal cancer. - have had a previous colonoscopy. - are severely ill and not able to visit the IEZ or other hospitals or medical centers or gastroenterological practices in the Rhine-Neckar region (Heidelberg, Mannheim, Rhine-Neckar-Kreis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The prevalences of advanced colorectal neoplasms including colorectal cancer, advanced adenoma or sessile serrated polyp > 1 cm. This will be assessed in a cross section of the general population aged 30-49 years with no previous early detection examination for colorectal cancer through the gold standard, colonoscopy and in addition according to levels of "polygenic risk scores or genetic risk scores" (PRS). PRS, based on multiple SNPs have recently been shown to be potentially very powerful tools for risk stratification far beyond the risk information based on self-reported family history of CRC or other established CRC risk factors. Given that PRS is a continuous trait with no “natural cutpoint”, we will classify participants according to quartiles of the PRS in the primary analysis, but additional analyses will be conducted to explore predictive ability and dose-response relationships across the entire range of PRS levels. A biobank will be set up in order to evaluate the PRS and further biomarkers or biomarker signatures that may be useful, by themselves or in combination with each other or the PRS, for early detection of advanced colorectal neoplasms or risk stratification in colorectal cancer screening. In addition, 2 questionnaires, which ask about lifestyle and general health, are used for risk stratification. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary point: The prevalence of any neoplasm. In LEO, this is assessed by the gold standard, colonoscopy, on the basis of a cross-section of the general population aged 30-49 years, without prior screening for colorectal cancer, and is additionally assessed with the so-called "polygenic risk score or genetic risk score" (PRS). PRS based on multiple SNPs have recently proven to be potentially very powerful risk stratification tools that go far beyond risk information based on self-reported family history of CRC or other established CRC risk factors. As PRS is a continuous feature without a "natural cutpoint", we will classify participants by quartiles of PRS in the primary analysis, but additional analyses will be performed to investigate predictive power and dose-response relationships across the range of PRS levels. A biobank will be established to evaluate the PRS and other biomarkers or biomarker signatures that, alone or in combination with each other or with the PRS, may be useful for the early detection of advanced colorectal neoplasia or risk stratification in colorectal cancer screening. In addition, 2 questionnaires, which ask about lifestyle and general health, are used for risk stratification. | — |
Countries
Germany
Contacts
Public ContactPetra Schrotz-King
Nationales Centrum für Tumorerkrankungen (NCT) und Deutsches Krebsforschungszentrum (DKFZ)
Outcome results
None listed