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

Inclusion Criteria1

  • Patients with a positive FOBT test result from the Colorectal Cancer Early Detection Program and referred for a colonoscopy.

Exclusion Criteria4

  • 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.

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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