Exploring Participant Preference for Screening Methods and Experience Into Colorectal Cancer Screening Programme

NCT ID: NCT06696534

Last Updated: 2025-10-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-19

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Screening for Colon Cancer Survey and Questionnaire

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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FIT/FOBT population

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

Group Type OTHER

Survey using a questionnaire.

Intervention Type OTHER

Preference questionnaire for colorectal cancer screening methods

Survey using a questionnaire.

Intervention Type OTHER

Experience questionnaire into colorectal cancer screening programme

Interventions

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Survey using a questionnaire.

Preference questionnaire for colorectal cancer screening methods

Intervention Type OTHER

Survey using a questionnaire.

Experience questionnaire into colorectal cancer screening programme

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SERMAS

UNKNOWN

Sponsor Role collaborator

ULS de Santa Maria

UNKNOWN

Sponsor Role collaborator

ADVANCED MARKER DISCOVERY S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria A Perez, MD

Role: PRINCIPAL_INVESTIGATOR

Primary Health Care Centre Mar Báltico

Ana Rita, MD

Role: PRINCIPAL_INVESTIGATOR

Unidade Local de Saúde de Santa Maria

Locations

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UCSP Sete Rios

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

CS Mar Báltico

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Portugal Spain

Central Contacts

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Marta Jimenez, PhD

Role: CONTACT

+34 637899149

Facility Contacts

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Ana Rita, MD

Role: primary

Maria A Perez, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25326034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38307102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36856579 (View on PubMed)

Other Identifiers

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2024-NDMH-5101_240046

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AMD-CCR-2024-01

Identifier Type: -

Identifier Source: org_study_id

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