RecruitingNCT06452745

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


Sponsor

Institut Investigacio Sanitaria Pere Virgili

Enrollment

2,000 participants

Start Date

Jul 20, 2019

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 50 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether analyzing metabolites (chemical byproducts of body processes) in blood or urine can detect colorectal cancer early and non-invasively. Patients referred for colonoscopy after a positive stool blood test are enrolled to compare metabolite profiles between those with and without cancer. **You may be eligible if...** - You had a positive fecal occult blood test (a stool test that detects hidden blood) and have been referred for a colonoscopy - You are participating in a colorectal cancer early detection program **You may NOT be eligible if...** - You have been diagnosed with another primary cancer in the past 5 years (except cervical carcinoma in situ or non-melanoma skin cancer) - You have severe kidney disease (creatinine clearance below 30 mL/min) - You have severe active liver disease such as hepatitis or cirrhosis - You refuse to sign the informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREColonoscopy

Colonoscopy performed as a regular practice during colorectal cancer screening.

OTHERUrine and FOBT collection

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


Locations(2)

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Hospital Universitari Joan XXIII

Tarragona, Tarragona, Spain

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NCT06452745


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