Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-15 @ 2:42 AM
Study NCT ID:
NCT02435602
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2015-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2015-05-01', 'studyFirstSubmitQcDate': '2015-05-05', 'lastUpdatePostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive predictive value', 'timeFrame': '2 years', 'description': 'The results of two methods are compare regarding positive predictive value.'}], 'secondaryOutcomes': [{'measure': 'Duration of the esophagoscopy ( NBI versus Lugol staining)', 'timeFrame': '2 years'}, {'measure': 'Evaluation of endoscopy ( NBI versus Lugol staining) tolerance using Visual Analogue Scale (VAS)', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endoscopy, gastrointestinal', 'cancer screening'], 'conditions': ['Esophageal Squamous Cell Carcinoma', 'Squamous Cell Carcinoma of the Head and Neck']}, 'descriptionModule': {'briefSummary': 'This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers.', 'detailedDescription': 'Patients with head and neck cancers have an increased risk for developing an esophageal squamous cell carcinoma (ESCC). Small, superficial, curable lesions are difficult to diagnose using only white light endoscopy. To improve detection chromoendoscopy is recommended. In this project patients are divided into two groups based on received chromoendoscopy (NBI versus Lugol). The results of two methods will be compare regarding positive predictive value to establish usage of chromoendoscopy in early detection of ESCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with past history ( \\>= 1 year ) of head and neck cancer treated curatively and receiving regular follow - up at the outpatient clinic of the Head and Neck Department of Maria Skłodowska - Curie Memorial Cancer Center, Institiut of Oncology\n* 18 years and older\n* Diagnosis of squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx\n* Zubrod scale 0-2\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Lack of written informed consent\n* Known allergy to iodine\n* Clinical conditions precluding upper GI endoscopy'}, 'identificationModule': {'nctId': 'NCT02435602', 'briefTitle': 'The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'The Role of Narrow Band Imaging (NBI) Endoscopy Compared With Lugol Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers: a Prospective Randomized Study', 'orgStudyIdInfo': {'id': '506-1-09-01-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NBI endoscopy', 'description': '* GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy\n* Biopsy at the visually abnormal lesions\n* Pathologic examination of all biopsy tissue specimens\n* Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus.', 'interventionNames': ['Procedure: NBI endoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lugol chromoendoscopy', 'description': '* GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy\n* Biopsy at the unstained lesions \\>= 5 mm diameter\n* Pathologic examination of all biopsy tissue specimens\n* Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus.', 'interventionNames': ['Procedure: Lugol chromoendoscopy']}], 'interventions': [{'name': 'NBI endoscopy', 'type': 'PROCEDURE', 'description': 'GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions', 'armGroupLabels': ['NBI endoscopy']}, {'name': 'Lugol chromoendoscopy', 'type': 'PROCEDURE', 'description': 'GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy Biopsy at the unstained lesions \\>= 5 mm diameter Pathologic examination of all biopsy tissue specimens', 'armGroupLabels': ['lugol chromoendoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Maria Sklodowska-curie Memorial Cancer Center, Institiute of Oncology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Jaroslaw Regula, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland'}, {'name': 'Anna Chaber-Ciopinska, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maria Sklodowska-Curie Memorial Cancer Center, Institiute of Oncology, Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre of Postgraduate Medical Education', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}