Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT02534818
Status:
UNKNOWN
Last Update Posted:
2015-11-10
First Post:
2015-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-11-07', 'studyFirstSubmitDate': '2015-08-25', 'studyFirstSubmitQcDate': '2015-08-27', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of the detection rate of gastric intestinal metaplasia between two fluosecein sodium dosage in a per-pateint analysis', 'timeFrame': 'six months'}, {'measure': 'Difference of the detection rate of gastric intestinal metaplasia between two dosage fluosecein sodium in a per-biopsy analysis', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastric Intestinal Metaplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.', 'detailedDescription': 'Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended.\n\nThis study aims to compare the diagnostic yield of gastric intestinal metaplasia from two different fluorescein sodium dosage and assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with dyspeptic symptoms and aged 40 years or older\n* or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis\n* or patients with family history of gastric cancer\n\nExclusion Criteria:\n\n* presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia\n* presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding\n* inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02534818', 'briefTitle': 'Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Conventional Fluorescein Sodium Dosage o.1ml/kg Compared With a Lower Fluorescein Sodium Dosage o.02ml/kg for the Detection of Gastric Intestinal Metaplasia in a High Risk Population: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2015SDU-QILU-G09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'lower fluorescein sodium dosage 0.02ml/kg for gastric intestinal metapalsia', 'interventionNames': ['Drug: lower fluorescein sodium dosage 0.02ml/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'conventional fluorescein sodium dosage 0.1ml/kg for gastric intestinal metapalsia', 'interventionNames': ['Drug: conventional fluorescein sodium dosage 0.1ml/kg']}], 'interventions': [{'name': 'lower fluorescein sodium dosage 0.02ml/kg', 'type': 'DRUG', 'description': 'fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia', 'armGroupLabels': ['Group 1']}, {'name': 'conventional fluorescein sodium dosage 0.1ml/kg', 'type': 'DRUG', 'description': 'fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqing Li, MD, PhD', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '86-531-82169236', 'phoneExt': '82169508'}], 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yanqing Li, PhD. MD', 'role': 'CONTACT', 'email': 'qiluliyanqing@gmail.com', 'phone': '18678827666', 'phoneExt': '82169508'}], 'overallOfficials': [{'name': 'Yanqing Li, PhD. MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Gastroenterology, Qilu Hospital, Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}