Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorADVANCED MARKER DISCOVERY S.L.
About this trial
This is a prospective, multicenter, case-control study. The aim is to develop an optimized algorithm by combining the levels of molecular markers in plasma together with risk factors for developing colorectal cancer and clinical data of patients diagnosed with CRC or AA and healthy individuals.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients over the age of 18 who are able to understand the participant information and sign the informed consent.
Patients who are going to undergo colonoscopy or surgical resection for tumor (CRC).
Disqualifiers
Patients who had developed any type of cancer in the 5 years prior to their participation in this study.
Patients who have received previous chemotherapy or radiotherapy.
Patients diagnosed with non-advanced adenomas, serrated polyps, Familial Adenomatous Polyposis or Lynch Syndrome.
Patients with inadequate bowel preparation for colonoscopy.
Trial population
This study involves the recruitment of 510 patients as part of a case-control study. Patients who are going to undergo colonoscopy or who are going to undergo surgery for resection of a CRC already diagnosed will be included. They can be symptomatic or asymptomatic, ambulatory, hospitalized or consecutive patients in the Endoscopy Unit.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
510 Participants
are grouped into 3 trial groupsGroup A: Healthy
Group B: Advanced Adenoma
Group C: Colorectal Cancer
Trial outcomes
Primary outcomes
1
Clinical Validation
To clinically validate the diagnostic capability of the algorithm for early detection of CRC and AA that combines molecular markers and risk factors
Time frame
36 monthsSponsors and contacts
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Source ClinicalTrials.gov