Actively Recruiting
Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile
Led by Institut Investigacio Sanitaria Pere Virgili · Updated on 2024-10-02
2000
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer is a common tumor affecting both men and women, with a high number of new cases and deaths each year, especially in people over 50 years old. This research aims to find if specific substances called metabolites in urine or stool can help detect colorectal cancer or polyps early in an easy and affordable way. Early detection is important because it can reduce cancer deaths and prevent polyps from turning into cancer. Participants will provide urine and stool samples before undergoing a colonoscopy, which is a procedure used to examine the colon and detect any abnormal growths or cancer. The study groups include patients diagnosed with colorectal cancer, those with various risk levels of adenomatous polyps, and healthy individuals with no lesions found during colonoscopy. Urine and fecal occult blood tests (FOBT) are collected prior to the colonoscopy and diet preparation. During the study, participants will have colonoscopy results reviewed within three months. Researchers will analyze urine and stool samples using metabolomics techniques to identify possible markers for early cancer detection. The study involves patients referred after a positive FOBT test and monitors their colonoscopy findings to assess potential non-invasive diagnostic methods. Participation duration varies, with primary outcomes measured three months after colonoscopy.
CONDITIONS
Brief Title
Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a positive fecal occult blood test (FOBT) result from the Colorectal Cancer Early Detection Program and referred for a colonoscopy.
- Adults aged 50 to 70 years.
You will not qualify if you...
- Patients diagnosed with another primary cancer in the last 5 years, except carcinoma in situ of the cervix or non-melanoma skin cancer.
- Patients with severe kidney disease stage IV (creatinine clearance less than 30 ml/min).
- Patients with severe active liver disease, including hepatitis or cirrhosis.
- Patients who refuse to sign informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo urine and fecal occult blood test collections followed by a colonoscopy performed as part of routine colorectal cancer screening.
1 visit for urine and fecal sample collection and 1 colonoscopy visit
Duration - Up to 10 years
Participants are observed based on their colonoscopy results, which may include colorectal cancer, adenomatous polyps of various risk levels, or no luminal lesions.
Visits depend on routine clinical follow-up and screening schedules
Trial Site Locations
Total: 2 locations
1
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain, 43204
Actively Recruiting
2
Hospital Universitari Joan XXIII
Tarragona, Tarragona, Spain, 43005
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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