The objective of this low-risk interventional study is to evaluate whether the PreveCol® test has sufficient efficiency to be considered as a second-line method for the detection of both colorectal cancer and advanced adenomas when used prospectively in the screening population with a previous positive FOBT result, which could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to be answered are: * Values of efficacy, efficiency, impact and safety of PreveCol. * Values of preferences of participants for screening methods. * Values of PREMs into screening programme. Participants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
4,538
PreveCol test based on blood sampling
Preference questionnaire for colorectal cancer screening methods
PREMs for colorectal cancer screening programme
Hospital de Santa Maria
Lisbon, Lisbon District, Portugal
NOT_YET_RECRUITINGHospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
RECRUITINGDiagnostic value
Value of efficiency through the clinical performance (sensitivity, specificity, positive predictive value and negative predictive value) of PreveCol® after FOBT positive result for detecting neoplastic lesions.
Time frame: 12 months
Diagnostic performance of cancer
Value of PreveCol's efficiency in second line for detecting cancer
Time frame: 12 months
Diagnostic performance of lesions
Value of PreveCol's efficiency in second line for advanced lesions
Time frame: 12 months
Value of questionnaires into screening programme
The percentage of number of answers from each preference questions and PREMs
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.