Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection

NCT06703632 | Recruiting

• 2 other identifiers: AMD-CCR-2024-022024-NDMH-5101_240046
• Study Type: interventional
• Target: 4,538
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic value

  Value of efficiency through the clinical performance (sensitivity, specificity, positive predictive value and negative predictive value) of PreveCol® after FOBT positive result for detecting neoplastic lesions.

  12 months

Secondary Outcomes (3)

• Diagnostic performance of cancer

  12 months

• Diagnostic performance of lesions

  12 months

• Value of questionnaires into screening programme

  12 months

Other Outcomes (1)

• Safety

  12 months

Study Arms (1)

PreveCol test after a FOBT positive result

OTHER

Average-risk participants from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy

Diagnostic Test: blood sampling; Other: Survey using a questionnaire.

Interventions

blood sampling DIAGNOSTIC_TEST

PreveCol test based on blood sampling

Also known as: PreveCol

PreveCol test after a FOBT positive result

Survey using a questionnaire. OTHER

Preference questionnaire for colorectal cancer screening methods

PreveCol test after a FOBT positive result

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ADVANCED MARKER DISCOVERY S.L.: lead
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital de Santa Maria, Lisbon: collaborator

Study Sites (2)

Hospital de Santa Maria

Lisbon, Lisbon District, Portugal

NOT YET RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, Madrid, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 36856579 BACKGROUND

• 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.

  PMID: 35914639 BACKGROUND

• 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.

  PMID: 28973514 BACKGROUND

• 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.

  PMID: 25856688 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Agustin Albillos, MD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

• Ana Rita, MD

  Hospital de Santa Maria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Jimenez, PhD

CONTACT

+34 637899149; mjimenez@amadix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Laboratory Technicians
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Low-risk interventional study

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: January 14, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); PT (1)