Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 9:14 PM
Study NCT ID:
NCT06696534
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Participant Preference for Screening Methods and Experience Into Colorectal Cancer Screening Programme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-16', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Value of questionnaires into screening programme', 'timeFrame': '12 months', 'description': 'The percentage of number of answers from each experience and preference questions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'screening programme', 'experience', 'preference', 'questionnaire'], 'conditions': ['Screening for Colon Cancer', 'Survey and Questionnaire']}, 'referencesModule': {'references': [{'pmid': '25326034', 'type': 'BACKGROUND', 'citation': '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': '38307102', 'type': 'BACKGROUND', 'citation': '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': '36856579', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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:\n\n* Values of experience of participants into screening programme.\n* Values of preferences of participants for screening methods.\n\nParticipants will answer two questionnaires and they'll be given their information and clinical data to investigator or health personnel."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants ages from 50 to 69 years (both included) at the time of informed consent signed.\n* Participants invited to participate in population-based screening programme who are eligible to undertake FOBT at the Primary Health Care Center.\n* 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.\n\nExclusion Criteria:\n\n* Participants who have not delivery a stool sample in the Primary Health Care Center before signing the informed consent form.\n* Participants with a previous colonoscopy in consequence of a FOBT positive result.\n* Participants who are in a dependent personal or non-medical relationship with the Sponsor or the Investigators.'}, 'identificationModule': {'nctId': 'NCT06696534', 'acronym': 'MS-Care', 'briefTitle': 'Exploring Participant Preference for Screening Methods and Experience Into Colorectal Cancer Screening Programme', 'organization': {'class': 'INDUSTRY', 'fullName': 'ADVANCED MARKER DISCOVERY S.L.'}, 'officialTitle': 'Exploring Participant Preference for Screening Methods and Experience Into Colorectal Cancer Screening Programme', 'orgStudyIdInfo': {'id': 'AMD-CCR-2024-01'}, 'secondaryIdInfos': [{'id': '2024-NDMH-5101_240046', 'type': 'OTHER_GRANT', 'domain': 'EIT-Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FIT/FOBT population', 'description': 'Average-risk population undergoing FIT/FOBT within the colorectal cancer screening programme.', 'interventionNames': ['Other: Survey using a questionnaire.']}], 'interventions': [{'name': 'Survey using a questionnaire.', 'type': 'OTHER', 'description': 'Preference questionnaire for colorectal cancer screening methods', 'armGroupLabels': ['FIT/FOBT population']}, {'name': 'Survey using a questionnaire.', 'type': 'OTHER', 'description': 'Experience questionnaire into colorectal cancer screening programme', 'armGroupLabels': ['FIT/FOBT population']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lisbon', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Ana Rita, MD', 'role': 'CONTACT'}], 'facility': 'UCSP Sete Rios', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria A Perez, MD', 'role': 'CONTACT'}], 'facility': 'CS Mar Báltico', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Marta Jimenez, PhD', 'role': 'CONTACT', 'email': 'mjimenez@amadix.com', 'phone': '+34 637899149'}], 'overallOfficials': [{'name': 'Maria A Perez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Primary Health Care Centre Mar Báltico'}, {'name': 'Ana Rita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidade Local de Saúde de Santa Maria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADVANCED MARKER DISCOVERY S.L.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'SERMAS', 'class': 'UNKNOWN'}, {'name': 'ULS de Santa Maria', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}