Observational Cross-reactivity Study for Colorectal Cancer Diagnosis
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorADVANCED MARKER DISCOVERY S.L.
About this trial
The objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. The main question to be answered is
Does the blood test have a low false positive rate in the main study population?
Participants will donate a blood sample as part of their regular medical care for cancer diagnosis and give the consent to know their clinical risk factors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years of age at the time of blood sample collection.
Subjects must be able to understand the information provided on the participant information sheet, must consent to participate in the study, and must sign the informed consent form.
Patients diagnosed with only one type of cancer (no colorectal cacner) or gastrointestinal disease.
Disqualifiers
Patients who have received previous chemotherapy or radiotherapy.
In case of diagnosis of a tumor: patients who have undergone total or partial surgical resection of the tumor.
Patients with a personal history of advanced or non-advanced colorectal adenoma, serrated lesions, colorectal cancer, familial adenomatous polyposis or Lynch syndrome.
Patients without appropriate staging or diagnosis.
Trial population
Patients will be enrolled with a only one diagnosis of cancer (no colorectal cancer) or gastrointestinal disease at the time of a consultation within the Oncology, Digestive System, Gastroenterology, Endoscopy or Surgery Service. Patients will be included in a competitive, consecutive and progressive manner by the Centers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood sampling
Diagnostic testPatients will donate a blood sample for molecular analysis of molecular biomarkers in plasma, which being the only procedure in the study.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Cancer or Gastrointestinal Disease1 intervention
Trial outcomes
Primary outcomes
1
False Positive Rate
To estimate the false positive rate of the blood-based test in the main population of the study
Time frame
36 monthSponsors and contacts
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Source ClinicalTrials.gov