Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-07 @ 4:33 AM
Study NCT ID:
NCT04943666
Status:
UNKNOWN
Last Update Posted:
2022-10-26
First Post:
2021-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-13', 'releaseDate': '2024-04-22'}], 'estimatedResultsFirstSubmitDate': '2024-04-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-25', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity of the HDQ for screening of patients with haemorrhoids', 'timeFrame': '1 month', 'description': "Objective examination by physicians will be made that is required to determine the sensitivity of the patient's HDQ."}, {'measure': 'specificity of the HDQ for screening of patients with haemorrhoids;', 'timeFrame': '1 month', 'description': "Objective examination by physicians will be made that is required to determine the specificity of the patient's HDQ"}], 'secondaryOutcomes': [{'measure': 'Prevalence rate of haemorrhoids among study population established by physicians basing on the results of the objective examination;', 'timeFrame': '1 month', 'description': '\\- to describe a prevalence of haemorrhoids among patients in the study'}, {'measure': 'Prevalence of the symptoms of haemorrhoids among patients in the study', 'timeFrame': '1 month', 'description': '\\- to describe a prevalence of the symptoms of haemorrhoids among patients in the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haemorrhoids']}, 'descriptionModule': {'briefSummary': "Currently in Russia there is no available self-evaluating tools with appropriate diagnostic accuracy for screening of patients with haemorrhoids. Therefore, the primary objective of this study is to evaluate a new patient specific questionnaire (HDQ) with appropriate sensitivity and specificity to use for screening of patients with haemorrhoids in Russia. Once evaluated, the HDQ will be used in clinical practice for wider screening of haemorrhoids in population and for increasing patients' awareness of the disease and prompting them to seek professional advice.\n\nSecondary objectives of the study are to describe a prevalence of haemorrhoids among patients in the study and to describe a prevalence of the symptoms of haemorrhoids among patients in the study", 'detailedDescription': 'Main parameters (primary outcomes) to be evaluated in the study are:\n\n1. sensitivity of the HDQ for screening of patients with haemorrhoids;\n2. specificity of the HDQ for screening of patients with haemorrhoids;\n\nAdditional parameters (secondary outcomes) in the study are:\n\n1. Prevalence rate of haemorrhoids among study population established by physicians basing on the results of the objective examination;\n2. Prevalence of the symptoms of haemorrhoids among patients in the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patients seeking help from a coloproctologist Limit: 450 characters.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient came to visit a coloproctologist\n* Male or female aged over 18 years\n* Signed informed consent form to participate in the study has been obtained\n* Absence of conditions requiring emergency medical care.\n* The patient is not taking VAD for at least 1 month before the date on inclusion to the study\n\nExclusion Criteria:\n\n* Confirmed or suspected malignant tumor\n* Diagnosed coloproctological disease at the time of inclusion\n* Severe somatic disorders (of heart and blood vessels, lungs, kidneys, pancreas, or liver), associated with decompensation of organ functions\n* Mental disorders\n* Presence of contraindications for examination'}, 'identificationModule': {'nctId': 'NCT04943666', 'acronym': 'HDQ', 'briefTitle': 'The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )', 'organization': {'class': 'INDUSTRY', 'fullName': 'Servier Russia'}, 'officialTitle': 'The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )', 'orgStudyIdInfo': {'id': 'IC4-05682-063-RUS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hemorrhoid Disease Questionnaire', 'type': 'OTHER', 'description': "a new patient specific questionnaire (HDQ) with appropriate sensitivity and specificity to use for screening of patients with haemorrhoids in Russia in clinical practice for wider screening of haemorrhoids in population and for increasing patients' awareness of the disease and prompting them to seek professional advice."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Yuriy Stoyko, Proff.', 'role': 'CONTACT', 'email': 'ystoyko@mail.ru', 'phone': '+7 985 784 88 60'}], 'facility': 'National Medical and Surgical Center. N.I. Pirogov', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Olga Linnik', 'role': 'CONTACT', 'email': 'olga.linnik@servier.com', 'phone': '+7 495 9370700', 'phoneExt': '1316'}], 'overallOfficials': [{'name': 'Yuriy Stoyko, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Servier Russia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-22', 'type': 'RELEASE'}, {'date': '2024-09-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Servier Russia'}}}}