About this trial
Colorectal cancer is the most frequent tumor in our environment if both sexes are considered together. Every year almost 800 cases are diagnosed in the districts of Tarragona. A little more than half of colorectal cancers are cured with surgery, with or without the addition of complementary treatments with chemotherapy and/or radiation therapy. Those who are not cured is because at the time of diagnosis the disease has already spread or they spread after having been treated surgically with curative intent.
The purpose of the EarlyCRC project is to determine whether metabolites (substances of low molecular weight) can be found in the urine and stool of patients with colorectal cancer or polyps that can be easily and cheaply differentiated (urine or stool analysis) between the patients affected by colorectal cancer or polyps, from healthy individuals. For the identification of these possible metabolites, the urine analysis will be performed using the usual techniques in metabolomics, which studies the existing metabolites in biological processes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a positive FOBT test result from the Colorectal Cancer Early Detection Program and referred for a colonoscopy.
Disqualifiers
Patients diagnosed with another primary neoplasm in the last 5 years, with the exception of carcinoma in situ of the cervix or non-melanoma skin cancer.
Patients with severe kidney disease stage IV (creatinine clearance < 30 ml/min).
Patients with severe active liver disease (hepatitis, cirrhosis).
Refusal to sign informed consent.
Trial population
The cohort subject to the study are patients participating in the population screening program for colorectal cancer with a positive fecal occult blood test (FOBT) who are called to undergo a colonoscopy.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Colonoscopy
Procedure/SurgeryColonoscopy performed as a regular practice during colorectal cancer screening.
Urine and FOBT collection
Other interventionAfter patients agreement, urine and FOBT are collected before the colonoscopy and before the diet preparation of the colon.
Treatment groups
Trial outcomes
Primary outcomes
Colonoscopy results
Histopathological analysis of biopsy and polypectomy pieces.
Sponsors and contacts
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