Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
NCT ID: NCT06703632
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4538 participants
INTERVENTIONAL
2025-01-14
2025-12-31
Brief Summary
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* Values of efficacy, efficiency, impact and safety of PreveCol.
* Values of preferences of participants for screening methods.
* Values of PREMs into screening programme.
Participants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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PreveCol test after a FOBT positive result
Average-risk participants from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy
blood sampling
PreveCol test based on blood sampling
Survey using a questionnaire.
Preference questionnaire for colorectal cancer screening methods
Survey using a questionnaire.
PREMs for colorectal cancer screening programme
Interventions
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blood sampling
PreveCol test based on blood sampling
Survey using a questionnaire.
Preference questionnaire for colorectal cancer screening methods
Survey using a questionnaire.
PREMs for colorectal cancer screening programme
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants should sign an informed consent. They must understand the nature, significance, implications, and risks of the clinical study before signing the informed consent form.
* Participants with a positive result of FIT/FOBT analysis referred to the gastroenterology department who are eligible to undertake colonoscopy as a regular procedure of the colorectal cancer screening programme.
* Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or over with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).
Exclusion Criteria
* Participants who have previously received chemotherapy or radiotherapy (5 years).
* Participants previously or currently diagnosed with Familiar Adenomatous Polyposis or Lynch Syndrome or Inflammatory Bowel Disease.
* Inadequate intestinal preparation for colonoscopy with BBPS score ≤1 in any colon section, excluding diagnostic of CRC.
* Participants who have undergone polypectomy in the previous 5 years.
* Hemolysis of blood sample or absence of blood sample.
* Participants who are arrested at judicial or official request
* Participants who are in a dependent personal or non-medical relationship with the Sponsor or the investigator.
50 Years
69 Years
ALL
Yes
Sponsors
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Hospital Universitario Ramon y Cajal
OTHER
Hospital de Santa Maria, Lisbon
UNKNOWN
ADVANCED MARKER DISCOVERY S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Agustin Albillos, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramon y Cajal
Ana Rita, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Santa Maria
Locations
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Hospital de Santa Maria
Lisbon, Lisbon District, Portugal
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Ana Rita, MD
Role: primary
Agustin Albillos, MD
Role: primary
References
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Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.
Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: [email protected]. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available.
Greuter MJE, de Klerk CM, Meijer GA, Dekker E, Coupe VMH. Screening for Colorectal Cancer With Fecal Immunochemical Testing With and Without Postpolypectomy Surveillance Colonoscopy: A Cost-Effectiveness Analysis. Ann Intern Med. 2017 Oct 17;167(8):544-554. doi: 10.7326/M16-2891. Epub 2017 Oct 3.
Bujanda L, Sarasqueta C, Castells A, Pellise M, Cubiella J, Gil I, Cosme A, Arana-Arri E, Mar I, Idigoras I, Portillo I; EUSCOLON Study Investigators. Colorectal cancer in a second round after a negative faecal immunochemical test. Eur J Gastroenterol Hepatol. 2015 Jul;27(7):813-8. doi: 10.1097/MEG.0000000000000366.
Other Identifiers
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2024-NDMH-5101_240046
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AMD-CCR-2024-02
Identifier Type: -
Identifier Source: org_study_id
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