Clinical trial NCT06703632: Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
Official title: Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Screening for Colon Cancer
Blood Samples
Survey and Questionnaire
Colorectal Carcinoma
Colon Adenocarcinoma
Precancerous Lesion of Colon
Keywords: colorectal cancer
screening programme
liquid biopsy
second line
questionnaire
Lead sponsor: ADVANCED MARKER DISCOVERY S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Ramon y Cajal
name: Hospital de Santa Maria, Lisbon
First posted: 2024-11-25
Enrollment: 4538
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Low-risk interventional study
Primary purpose: SCREENING

Brief summary: The objective of this low-risk interventional study is to evaluate whether the PreveCol® test has sufficient efficiency to be considered as a second-line method for the detection of both colorectal cancer and advanced adenomas when used prospectively in the screening population with a previous positive FOBT result, which could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to be answered are:

* 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.


Eligibility criteria: Inclusion Criteria:

* Participants ages from 50 to 69 years (both included) at the time of informed consent signed.
* 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 developed any another type of cancer in the 5 years prior to their participation in the study.
* 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.

Primary outcomes:
measure: Diagnostic value
timeFrame: 12 months
Secondary outcomes:
measure: Diagnostic performance of cancer
timeFrame: 12 months
measure: Diagnostic performance of lesions
timeFrame: 12 months
measure: Value of questionnaires into screening programme
timeFrame: 12 months
Other outcomes:
measure: Safety
timeFrame: 12 months
Locations:
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: Agustin Albillos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Santa Maria
name: Ana Rita, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. 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.
citation: 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.
citation: 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.