Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-04 @ 1:33 AM
Study NCT ID:
NCT03214835
Status:
WITHDRAWN
Last Update Posted:
2020-07-20
First Post:
2017-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D057045', 'term': 'Laryngopharyngeal Reflux'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study halted prematurely, prior to enrollment of first participant.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-16', 'studyFirstSubmitDate': '2017-07-10', 'studyFirstSubmitQcDate': '2017-07-10', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of EndoCDx brush', 'timeFrame': '3 months', 'description': 'Efficacy of EndoCDx brush biopsy as a diagnostic tool for laryngeal lesions compared to cup forceps biopsy and a diagnostic tool for LPR compared to double probe PH monitoring'}], 'secondaryOutcomes': [{'measure': 'Assessment of pain', 'timeFrame': '6 months', 'description': 'Assessment of pain during EndoCDx brush biopsy under local anesthesia by Visual Analog Score for pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Larynx', 'reflux', 'LPR', 'tumor', 'lesion'], 'conditions': ['Laryngeal Disease', 'Laryngeal Tumor', 'Laryngopharyngeal Reflux']}, 'descriptionModule': {'briefSummary': 'The study will take place at Rambam medical center, department of Otolaryngology Head and Neck Surgery, for two years. Patients suspected of LPR or laryngeal l tumor and are candidate for laryngeal or hypopharyngeal biopsies will be recruited.', 'detailedDescription': 'First- all patients visiting our clinic with laryngeal complaints suspicious for either LPR or laryngeal tumor will fill the RSI questionnaire. Then fiberoptic examination will be performed by a laryngologist that will complete the RFS score.\n\nPatients with suspicious lesions will be referred for TFL standard biopsy and CDx brush biopsy in order to determine whether the lesions are malignant or benign. The pathologic diagnosis of invasive carcinoma from a TFL biopsy is considered equivalent to the pathology results from a direct laryngoscopy biopsy. All patients with benign pathology or carcinoma in-situ (CIS) on TFL biopsy will be referred for subsequent direct laryngoscopy (DL) for definitive diagnosis. At the time of the DL biopsy will include also another CDx brush smear. Patients with benign-appearing lesions will be taken for lesion removal and biopsy.Before removal of the lesion a CDx brush smear will be collected.\n\nAll the participants suspected of LPR will have: PHmetry with Manometry andCDx brush biopsy.All relevant demographic and clinical data will be retrieved for analysis.\n\nCDx biopsies will be an addition to the routine management of the patients in the diagnosis and follow-up of laryngeal lesions and LPR and will not replace the standard regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or over\n* patients suspected to suffer from LPR\n* Patients with laryngeal/hypopharyngeal lesions.\n\nExclusion Criteria:\n\n* Patient refusal\n* Patients with anatomical variants which precludes biopsy taking.\n* Patients with allergy to lidocain-based local anesthesia agents.'}, 'identificationModule': {'nctId': 'NCT03214835', 'briefTitle': 'CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'CDx Diagnostics'}, 'officialTitle': 'CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions', 'orgStudyIdInfo': {'id': 'CDx Laryngeal and LPR Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brush biopsy for laryngeal lesion', 'description': 'Brush biopsy of the larynx - in addition to the standard biopsy', 'interventionNames': ['Device: Endo CDx Brush biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Brush biopsy for LPR', 'description': 'Brush biopsy of the larynx at the post cricoid region - in addition to the standard examination for LPR (PH monitoring double probe)', 'interventionNames': ['Device: Endo CDx Brush biopsy']}], 'interventions': [{'name': 'Endo CDx Brush biopsy', 'type': 'DEVICE', 'description': 'In patients with laryngeal lesion the brush biopsy will be taken with the standard cup biopsy - either in the clinic or in the OR. In LPR patients brush biopsy will be taken in the clinic.', 'armGroupLabels': ['Brush biopsy for LPR', 'Brush biopsy for laryngeal lesion']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jacob Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CDx Diagnostics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Rambam Health Care Campus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}