Colorectal cancer statistics, 2023.
Rebecca L Siegel, Nikita Sandeep Wagle, Andrea Cercek...
https://pubmed.ncbi.nlm.nih.gov/36856579Actively Recruiting
Phase Not Applicable
Age: 50Years - 69Years
All Genders
Healthy Volunteers
ID06703632
Evaluation of PreveCol's Efficiency As a Second Line Method for Early Colorectal Cancer Detection
Led by ADVANCED MARKER DISCOVERY S.L. · Updated on 2025-02-27
4538
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
A
ADVANCED MARKER DISCOVERY S.L.
Lead Sponsor
H
Hospital Universitario Ramon y Cajal
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficiency of the PreveCol® test as a second-line method to detect colorectal cancer and advanced adenomas in people aged 50 to 69 years who have a previous positive result from a fecal occult blood test (FOBT). This low-risk interventional study aims to assess the test's effectiveness, impact, safety, participant preferences for screening methods, and patient-reported experience measures (PREMs) within the screening program. Participants will provide a blood sample for the PreveCol test before undergoing a screening colonoscopy. They will also complete two questionnaires: one about their screening method preferences and another capturing their experience with the screening program. The study focuses on average-risk individuals who are asymptomatic and eligible for colonoscopy after a positive FOBT. During the study, researchers will collect blood samples, clinical data, and questionnaire responses. They will evaluate diagnostic values related to colorectal cancer and lesion detection over 12 months. The study includes safety monitoring and aims to understand the impact and preferences associated with colorectal cancer screening methods. Participation involves providing samples and completing questionnaires alongside routine colonoscopy.
CONDITIONS
Brief Title
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
Who Can Participate
Age: 50Years - 69Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Participants aged 50 to 69 years at the time of informed consent
- Participants must sign informed consent and understand the study
- Positive fecal immunochemical test (FIT) or fecal occult blood test (FOBT) result and eligible for colonoscopy
- Asymptomatic, average risk for colorectal cancer with no personal or family history of colorectal cancer, adenoma, or inflammatory bowel disease
You will not qualify if you...
- History of any other cancer within the past 5 years
- Prior chemotherapy or radiotherapy within the past 5 years
- Diagnosis of Familial Adenomatous Polyposis, Lynch Syndrome, or Inflammatory Bowel Disease
- Inadequate intestinal preparation for colonoscopy (BBPS score 6lt;=1 in any colon section, excluding colorectal cancer diagnosis)
- Polypectomy within the previous 5 years
- Hemolysis or absence of blood sample
- Under judicial or official detention
- Dependent personal or non-medical relationship with the Sponsor or investigator
AI-Screening
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1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surveillance
Duration - 12 months
Participants undergo the PreveCol test based on blood sampling and complete questionnaires about colorectal cancer screening methods and experiences.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Hospital de Santa Maria
Lisbon, Lisbon District, Portugal
Not Yet Recruiting
2
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
Actively Recruiting
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Research Team
M
Marta Jimenez, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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Published Research Related To This Trial
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F Lordick, F Carneiro, S Cascinu...
https://pubmed.ncbi.nlm.nih.gov/35914639Screening for Colorectal Cancer With Fecal Immunochemical Testing With and Without Postpolypectomy Surveillance Colonoscopy: A Cost-Effectiveness Analysis.
Marjolein J E Greuter, Clasine M de Klerk, Gerrit A Meijer...
https://pubmed.ncbi.nlm.nih.gov/28973514Colorectal cancer in a second round after a negative faecal immunochemical test.
Luis Bujanda, Cristina Sarasqueta, Antoni Castells...
https://pubmed.ncbi.nlm.nih.gov/25856688