Advanced Adenomas (AA), Colorectal Cancer Screening
Conditions
Keywords
colon and rectum cancer, in vitro diagnostic, liquid biopsy, screening programme
Brief summary
The goal of this Multicentre and international prospective study is to validate a molecular signature using plasma samples in average-risk population for colorectal cancer who undergo colonoscopy in a screening setting. The main question it aims to answer is: Does molecular signature in plasma sample have higher diagnostic accuracy than FIT for early detection of colorectal cancer? Participants who already have a colonoscopy as part of their regular medical care for colorectal cancer screening will provide a stool sample and a plasma sample.
Interventions
DIAGNOSTIC_TESTblood sampling
Molecular signature using plasma sample
OTHERstool sampling
Stool sampling (by the participant)
OTHERcolonoscopy
Colonoscopy will be performed in the course of a screening programme
Sponsors
European Union H2020 SME Instrument
ADVANCED MARKER DISCOVERY S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
Laboratory Technicians
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants between the ages of 50 and 75 (both included) at the time of informed consent signed. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form. * Participants referred to the gastroenterology service who are going to undertake colonoscopy as a regular procedure for screening setting. * Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or older with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).
Exclusion criteria
* Participants between the ages of 50 and 75 (both included) at the time of Informed consent signature. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form. * Participants who have been diagnosed with CRC. The diagnosis must be subsequently confirmed by biopsy or surgery and pathological anatomy analysis during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate the diagnosis capacity of molecular signature in plasma samples | 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Demonstrate superiority of molecular signature in plasma samples compared with FIT | 48 months |
Other
| Measure | Time frame |
|---|---|
| Performance of molecular signature in plasma samples (Diagnostic capability) in cases of false positive or false negatives obtained in FIT | 48 months |
Countries
Germany, Poland
Outcome results
None listed