C18 C19 C20
Conditions
Interventions
Group 1: Screening patients of a colonoscopy (screening and diagnostic), Biosamples taken are: blood, urine, saliva, stool. Questions about lifestyle and health behavior.
Group 2: Screening patients o
Sponsors
Nationales Centrum für Tumorerkrankungen (NCT) und Deutsches Krebsforschungszentrum (DKFZ)
Eligibility
Sex/Gender
All
Age
50 Years to 54 Years
Inclusion criteria
Inclusion criteria: Women or men - Age 50 (>49) to 54 (<55) 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, who have a history of colorectal cancer. - have had a colonoscopy in the previous 5 years. - have a history of FAP (Familial Adenomatous Polyposis) or Lynch Syndrome. - are severely ill and not able to visit the IEZ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study Part I: Frequency of previous early detection examinations. Collected at the end of the study as soon as all questionnaire data have been recorded, checked for plausibility and evaluated. Study Part II: Proportion of participants in whom colorectal neoplasms > 0.5 cm that are detected and removed at screening endoscopy. Collected at the end of the study as soon as all endoscopy data have been recorded, checked for plausibility and evaluated. Study Part III: Sensitivity, specificity, positive and negative predictive values, area under the curve (AUC) of diagnostic tests for detection of CRC and colorectal adenomas. Collected after the end of the study, as soon as bioprobes and associated medical data are included in biosamples analyses of different kinds (for example, metabolomics, proteomics, miRNA, SPS, Expression analysis, sequencing). | — |
Secondary
| Measure | Time frame |
|---|---|
| Utilization rate of any screening endoscopy. Detection rate of any neoplasm. Patient preference with respect to type of screening endoscopy (proportion). Safety of the applied procedures, complication rates (established routine procedures, standard monitoring of complications). Collected at the end of the study as soon as all endoscopy data has been recorded, checked for plausibility and evaluated. | — |
Countries
Germany
Contacts
Public ContactPetra Schrotz-King
DARIO Studie, Abteilung Primäre Krebsprävention, ehemalig Präventive Onkologie, NCT/DKFZ Im Neuenheimer Feld 460 69120 Heidelberg Deutschland
Outcome results
None listed