Observational Cross-reactivity Study for Colorectal Cancer Diagnosis
Recruiting · NCT06889844 · Observational (researchers observe without assigning treatment) · Lead sponsor: ADVANCED MARKER DISCOVERY S.L.
View the official record on ClinicalTrials.gov →Interventions studied
blood sampling
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Patients with hemolyzed plasma.
Where it is running
5 locations listed.
- Hospitales HM de Malaga - Málaga, Andalusia, Spain
- Hospital Centro Médico Asturias - Oviedo, Cantabria, Spain
- Hospital Universitario de Ourense - Ourense, Galicia, Spain
- Hospital Universitario HM Sanchinarro - Madrid, Madrid, Spain
- MD Anderson Cancer Centre - Madrid, Madrid, Spain