Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05689918
Status:
UNKNOWN
Last Update Posted:
2023-01-19
First Post:
2022-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastroesophageal Reflux Disease in the Dutch Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4719}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-05-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-16', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of GERD symptoms (heartburn, regurgitation and/or dyspepsia)', 'timeFrame': '7 days', 'description': 'The Dutch translation of the validated Reflux Disease Questionnaire will be used to measure this outcome.'}, {'measure': 'Level of awareness of esophageal cancer risk factors and alarm symptoms', 'timeFrame': 'Baseline', 'description': "The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The alarm symptom module measures whether participants think dysphagia, change in stool pattern, change in appearance of a mole, weightloss and palpable lesions are alarm symptoms of cancer (yes/no/don't know). The risk factor module measures whether participants think alcohol, smoking, obesity, male sex, GERD symptoms, age\\>50y, familial esophageal cancer, hot drinks and radiation are risk factors for esophageal cancer on a 4 point scale (strongly disagree - strongly agree)."}], 'secondaryOutcomes': [{'measure': 'Number of individuals that sought help for GERD (general practitioner/referral)', 'timeFrame': '20 years', 'description': 'Participants with GERD will be asked whether they discussed their symptoms with their GP, whether they have been referred to a gastroenterologist or internist and what their reasons were for seeking help or not seeking help (answer options were based on qualitative research).'}, {'measure': "Number of individuals with GERD that used antacids, H2RAs and PPI's (prescribed)", 'timeFrame': '6 months', 'description': 'Participants will be asked to indicate whether they used prescribed Omeprazol, Pantoprazol, Esomeprazol, Lansoprazol, Rabeprazol, Cimetidine, Famotidine, Nizatidine, Ranitidine, Sucralfate, Misoprostol, Antagel, Gastilox, Maalox, Gaviscon, Regla-pH, Rennie, Magnesiumhydroxide, Iberogast or A. Vogel Boldocynara in the past 6 months.'}, {'measure': "Number of individuals with GERD that used antacids, H2RAs and PPI's (over-the-counter)", 'timeFrame': '6 months', 'description': 'Participants will be asked to indicate whether they used over-the-counter Omeprazol, Pantoprazol, Esomeprazol, Lansoprazol, Rabeprazol, Cimetidine, Famotidine, Nizatidine, Ranitidine, Sucralfate, Misoprostol, Antagel, Gastilox, Maalox, Gaviscon, Regla-pH, Rennie, Magnesiumhydroxide, Iberogast or A. Vogel Boldocynara in the past 6 months.'}, {'measure': 'Beliefs about esophageal cancer', 'timeFrame': 'Baseline', 'description': 'The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The beliefs module measures whether participants think esophageal cancer can be treated, can be cured, is a death sentence, can benefit from early detection and whether they would wish to know about de diagnosis on a 4 point Likerts scale (strongly disagree - strongly agree).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastro Esophageal Reflux']}, 'descriptionModule': {'briefSummary': 'Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may help to decrease mortality of this malignancy. To understand the size of the target population for potential EAC screening, insight in the prevalence of registered and unregistered individuals with gastro-esophageal reflux disease (GERD) symptoms is needed. Insight in public awareness of EAC will provide additional useful information for public communication strategies.\n\nObjective: The aims of this study are to assess the prevalence of GERD symptoms and related help-seeking behavior, registered and unregistered medication use and awareness of esophageal cancer in the general Dutch population.\n\nStudy design: Cross-sectional population-based survey.\n\nStudy population: Dutch citizens aged 18-75 years.\n\nMethods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey.\n\nMain study parameters/endpoints: The outcome variables are presence of current GERD symptoms, number of GERD patients that consulted a doctor, number of GERD patients using prescribed and/or over the counter (OTC) antacids, histamine-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), and awareness and beliefs about esophageal cancer. The association between socio-demographic background and outcome variables will also be evaluated.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study.\n\nNonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Dutch population registry, 'Basisregistratie Personen' (BRP).", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 75 years\n\nExclusion Criteria:\n\n* Unable to provide informed consent for any reason;\n* Unable to fill out the digital survey for any reason.'}, 'identificationModule': {'nctId': 'NCT05689918', 'acronym': 'REFLUX', 'briefTitle': 'Gastroesophageal Reflux Disease in the Dutch Population', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Gastroesophageal Reflux Symptoms and Help-seeking Behavior, Medication Use and Esophageal Cancer Awareness: Dutch Population-based Survey', 'orgStudyIdInfo': {'id': '2022-13720'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}