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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 70
Healthy Volunteers: f
View:

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

Locations
Other Locations
Spain
Hospital Universitari Sant Joan de Reus
RECRUITING
Reus
Hospital Universitari Joan XXIII
RECRUITING
Tarragona
Time Frame
Start Date: 2019-07-20
Estimated Completion Date: 2040-06-30
Participants
Target number of participants: 2000
Treatments
Colorectal Cancer
Diagnosed colorectal cancer after histopathological analysis of biopsy and polypectomy pieces taken within a colonoscopy.
Adenomatous high risk polyps
Diagnosed adenomatous high risk polyps after histopathological analysis of biopsy and polypectomy pieces taken within a colonoscopy. With = or \> 10 adenomas or serrated polyps and/or any sessile or flat lesion of = or \>20 mm (pediculated = or \>20 mm are not high risk).
Adenomatous medium risk polyps
Diagnosed adenomatous medium risk polyps after histopathological analysis of biopsy and polypectomy pieces taken within a colonoscopy. With 5 to 9 non-advanced serrated adenomas or polyps and/or at least 1 advanced lesion (adenoma \>10mm and/or hairy component and/or high-grade dysplasia or serrated polyp \>10mm and/or dysplasia).
Adenomatous low risk polyps
Diagnosed adenomatous low risk polyps after histopathological analysis of biopsy and polypectomy pieces taken within a colonoscopy. With 1 to 4 non-advanced adenomas (\<10mm, without hairy component or high-grade dysplasia) or non-advanced serrated polyps (\<10mm, without dysplasia).
Healthy
No luminal lesions are observed during the colonoscopy.
Related Therapeutic Areas
Sponsors
Leads: Institut Investigacio Sanitaria Pere Virgili

This content was sourced from clinicaltrials.gov