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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-70
SponsorInstitut Investigacio Sanitaria Pere Virgili

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Colonoscopy

    Procedure/Surgery

    Colonoscopy performed as a regular practice during colorectal cancer screening.

  • Urine and FOBT collection

    Other intervention

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

Treatment groups

2,000 Participants
are divided into 5 treatment groups
Group A: Colorectal Cancer2 interventions
Group B: Adenomatous high risk polyps2 interventions
Group C: Adenomatous medium risk polyps2 interventions
Group D: Adenomatous low risk polyps2 interventions
Group E: Healthy2 interventions

Trial outcomes

Primary outcomes

1

Colonoscopy results

Histopathological analysis of biopsy and polypectomy pieces.

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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