Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT00583934
Status:
COMPLETED
Last Update Posted:
2010-07-13
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Screening for Esophageal Pathology in Asymptomatic Patients Post-Treatment for Head and Neck Cancer Beneficial?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-12', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early detection of esophageal cancer or dysplasia in patients without symptoms, after treating their primary cancer, may improve their chances of being cured of a secondary disease.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['esophageal cancer, head and neck cancer, dysplasia'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the prevalence of esophageal pathology in asymptomatic patients with a history of head and neck cancer.', 'detailedDescription': "There are certain factors (i.e. alcohol, tobacco, decreased saliva production from radiation) that predispose patients with a history of head and neck cancer to have esophageal disease. Often, in the initial stages of the disease, patients do not have symptoms. However, the early detection of precancerous lesions or small cancers improves patients' chances of being cured. There is no direct data supporting the practice of screening patients with a history of head and neck cancer after treatment for esophageal disease if they are not experiencing symptoms. However, many argue that screening endoscopy is justified in high risk patients to detect early esophageal cancer or dysplasia at a curable state. We are, therefore, performing this study to determine the value of endoscopic screening of the esophagus after treatment for head and neck cancer in patients without symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subject population will be recruited from the clinical practice of the investigators.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Head and neck cancer patients that are six months post treatment and asymptomatic for esophageal disease.\n\nExclusion Criteria:\n\n* None if meets the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT00583934', 'briefTitle': 'Is Screening for Esophageal Pathology in Asymptomatic Patients Post-Treatment for Head and Neck Cancer Beneficial?', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Is Screening for Esophageal Pathology in Asymptomatic Patients Post-Treatment for Head and Neck Cancer Beneficial?', 'orgStudyIdInfo': {'id': '200513668-3'}, 'secondaryIdInfos': [{'id': '00004557'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Those six months post treatment for head and neck cancer.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Gregory Farwell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gregory Farwell, MD', 'oldOrganization': 'University of California, Davis'}}}}