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Screening for Colon CancerMS-PrevecolNCT06703632

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

A study testing blood sampling and Survey using a questionnaire. in people with Screening for Colon Cancer and Blood Samples, run by ADVANCED MARKER DISCOVERY S.L. at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 69 yearsHealthy volunteers can take part
What is being tested?
blood sampling and Survey using a questionnaire.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,538 participants
Where
2 sitesin 2 countries
Study dates
14 Jan 2025to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Marta Jimenez, PhD contact

+34 637899149

mjimenez@amadix.com

2 sites in 2 countries

Portugal1 site, 1 recruiting

  • Hospital de Santa Maria

    Lisbon, Lisbon District

    Ana Rita, MD

    Not yet recruiting

Other trials in Portugal

Spain1 site, 1 recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid

    Agustin Albillos, MD

    Recruiting

Other trials in Spain

About this study

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.

Being tested
blood sampling, Survey using a questionnaire.
Keywords
colorectal cancer, screening programme, liquid biopsy, second line, questionnaire
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood samplingDiagnostic test

    Also called PreveCol

    PreveCol test based on blood sampling

  • Survey using a questionnaire.Other

    Preference questionnaire for colorectal cancer screening methods

  • Survey using a questionnaire.Other

    PREMs for colorectal cancer screening programme

Study groups in NCT06703632
Study groupRoleWhat they receive
PreveCol test after a FOBT positive resultOtherAverage-risk participants from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy
Receives: Diagnostic Test: blood sampling; Other: Survey using a questionnaire.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (3)

  1. Diagnostic performance of cancer

    Value of PreveCol's efficiency in second line for detecting cancer

    Measured: 12 months

  2. Diagnostic performance of lesions

    Value of PreveCol's efficiency in second line for advanced lesions

    Measured: 12 months

  3. Value of questionnaires into screening programme

    The percentage of number of answers from each preference questions and PREMs

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start14 Jan 2025
  3. Primary completionNov 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
Low-risk interventional study
Masking
None (open label)
Enrolment
4,538 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06703632
Sponsor's protocol ID
AMD-CCR-2024-02
Other IDs
2024-NDMH-5101_240046
Acronym
MS-Prevecol
Status last verified
Nov 2024
First submitted
19 Nov 2024
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36856579

  • 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.

    PubMed 35914639

  • 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.

    PubMed 28973514

  • 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.

    PubMed 25856688

Questions about this trial

What is this clinical trial studying?

A study testing blood sampling and Survey using a questionnaire. in people with Screening for Colon Cancer and Blood Samples, run by ADVANCED MARKER DISCOVERY S.L. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marta Jimenez, PhD (+34 637899149, mjimenez@amadix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic value (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06703632, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.

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