NCT06696534

Brief Summary

The goal of this low-risk interventional study is to analyze participants' assessment of colorectal cancer screening program through screening method preference and experience after FOBT analysis in screaned participant population for colorectal cancer; could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to answer are:

  • Values of experience of participants into screening programme.
  • Values of preferences of participants for screening methods. Participants will answer two questionnaires and they'll be given their information and clinical data to investigator or health personnel.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

May 19, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

November 12, 2024

Last Update Submit

September 29, 2025

Conditions

Screening for Colon CancerSurvey and Questionnaire

Keywords

colorectal cancerscreening programmeexperiencepreferencequestionnaire

Outcome Measures

Primary Outcomes (1)

  • Value of questionnaires into screening programme

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

    12 months

Study Arms (1)

FIT/FOBT population

OTHER

Average-risk population undergoing FIT/FOBT within the colorectal cancer screening programme.

Other: Survey using a questionnaire.

Interventions

Survey using a questionnaire.OTHER

Preference questionnaire for colorectal cancer screening methods

FIT/FOBT population

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 invited to participate in population-based screening programme who are eligible to undertake FOBT at the Primary Health Care Center.
  • 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.

You may not qualify if:

  • Participants who have not delivery a stool sample in the Primary Health Care Center before signing the informed consent form.
  • Participants with a previous colonoscopy in consequence of a FOBT positive result.
  • Participants who are in a dependent personal or non-medical relationship with the Sponsor or the Investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSP Sete Rios

Lisbon, Portugal

NOT YET RECRUITING

CS Mar Báltico

Madrid, Madrid, Spain

RECRUITING

Related Publications (3)

  • Adler A, Geiger S, Keil A, Bias H, Schatz P, deVos T, Dhein J, Zimmermann M, Tauber R, Wiedenmann B. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol. 2014 Oct 17;14:183. doi: 10.1186/1471-230X-14-183.

    PMID: 25326034BACKGROUND

  • De Angelis R, Demuru E, Baili P, Troussard X, Katalinic A, Chirlaque Lopez MD, Innos K, Santaquilani M, Blum M, Ventura L, Paapsi K, Galasso R, Guevara M, Randi G, Bettio M, Botta L, Guzzinati S, Dal Maso L, Rossi S; EUROCARE-6 Working Group. Complete cancer prevalence in Europe in 2020 by disease duration and country (EUROCARE-6): a population-based study. Lancet Oncol. 2024 Mar;25(3):293-307. doi: 10.1016/S1470-2045(23)00646-0. Epub 2024 Jan 30.

    PMID: 38307102BACKGROUND

  • 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: 36856579BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Maria A Perez, MD

    Primary Health Care Centre Mar Báltico

    PRINCIPAL INVESTIGATOR

  • Ana Rita, MD

    Unidade Local de Saúde de Santa Maria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Jimenez, PhD

CONTACT

+34 637899149mjimenez@amadix.com

Study Design

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

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 20, 2024

Study Start

May 19, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)PT(1)