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Clinical Trials in Spain / NCT06452745
Recruiting Observational

Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile

NCT06452745 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2019-07-20
Last updated
2024-10-02

Condition(s) studied

Colorectal CancerColorectal AdenomaColorectal PolypHealthy

Investigational drug(s) / intervention(s)

ColonoscopyUrine and FOBT collection

Colonoscopy: Colonoscopy performed as a regular practice during colorectal cancer screening.

Urine and FOBT collection: After patients agreement, urine and FOBT are collected before the colonoscopy and before the diet preparation of the colon.

Study summary

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

Sex
ALL
Min age
50 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with a positive FOBT test result from the Colorectal Cancer Early Detection Program and referred for a colonoscopy. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Hospital Universitari Sant Joan de Reus Reus Tarragona Recruiting
Hospital Universitari Joan XXIII Tarragona Tarragona Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06452745 on ClinicalTrials.gov ↗ ← All trials in Spain