Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile
EarlyCRC
1 other identifier
observational
2,000
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2019
CompletedFirst Submitted
Initial submission to the registry
June 5, 2024
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2040
October 2, 2024
June 1, 2024
11 years
June 5, 2024
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colonoscopy results
Histopathological analysis of biopsy and polypectomy pieces.
3 months
Study Arms (5)
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.
Interventions
Colonoscopy performed as a regular practice during colorectal cancer screening.
After patients agreement, urine and FOBT are collected before the colonoscopy and before the diet preparation of the colon.
Eligibility Criteria
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.
You may qualify if:
- Patients with a positive FOBT test result from the Colorectal Cancer Early Detection Program and referred for a colonoscopy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Hospital Universitari Joan XXIII
Tarragona, Tarragona, 43005, Spain
Biospecimen
Urine and FOBT samples collected before colonoscopy and before colon diet preparation.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 5, 2024
First Posted
June 11, 2024
Study Start
July 20, 2019
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2040
Last Updated
October 2, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share