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.
Participants ages from 50 to 69 years (both included) at the time of informed consent signed.
Participants should sign an informed consent. They must understand the nature, significance, implications, and risks of the clinical study before signing the informed consent form.
Participants with a positive result of FIT/FOBT analysis referred to the gastroenterology department who are eligible to undertake colonoscopy as a regular procedure of the colorectal cancer screening programme.
Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or over with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).
Participants who have developed any another type of cancer in the 5 years prior to their participation in the study.
Participants who have previously received chemotherapy or radiotherapy (5 years).
Participants previously or currently diagnosed with Familiar Adenomatous Polyposis or Lynch Syndrome or Inflammatory Bowel Disease.
Inadequate intestinal preparation for colonoscopy with BBPS score ≤1 in any colon section, excluding diagnostic of CRC.
Single group
blood sampling
Diagnostic testPreveCol test based on blood sampling
Survey using a questionnaire.
Other interventionPreference questionnaire for colorectal cancer screening methods
Survey using a questionnaire.
Other interventionPREMs for colorectal cancer screening programme
Diagnostic 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.
Diagnostic performance of cancer
Value of PreveCol's efficiency in second line for detecting cancer
Diagnostic performance of lesions
Value of PreveCol's efficiency in second line for advanced lesions
Value of questionnaires into screening programme
The percentage of number of answers from each preference questions and PREMs
Safety
Measure the percentage of adverse events and complications directly/indirectly related to interventions of study.
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ADVANCED MARKER DISCOVERY S.L.
Lead sponsor
Hospital Universitario Ramon y Cajal
Collaborator
Hospital de Santa Maria, Lisbon
Collaborator
