Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT01972802
Status:
UNKNOWN
Last Update Posted:
2013-10-30
First Post:
2013-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
International Cancer of the Head and Neck, Genetics and Environment (InterCHANGE) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'BLOOD 20ML, Fresh (biopsy)samples, Oral scrape'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-29', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-10-29', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'head and neck cancer risk factor', 'timeFrame': 'Four years', 'description': 'evaluate the association between certain environmental exposures (e.g. cigarette smoking, alcohol drinking, betel nut chewing…) and head and neck cancers,assess the effect of genetic factors, including both SNP and copy number variation (CNV) through analysis of both main effect and gene-gene interaction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HEAD AND NECK'], 'conditions': ['Evaluate the Association Between Certain Environmental Exposures (e.g. Cigarette Smoking, Alcohol Drinking, Betel Nut Chewing…) and Head and Neck Cancers', 'Assess the Effect of Genetic Factors, Including Both SNP and Copy Number Variation (CNV) Through Analysis of Both Main Effect and Gene-gene Interaction']}, 'descriptionModule': {'briefSummary': 'Our overall objective is to understand the role of lifestyle factors, genetics and HPV infection in the development and prognosis of head and neck cancer particularly in Asia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'NTUH HEAD AND NECK PATIENT AND CONTROLS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18\\~80 Incident head and neck cancer patients\n\n* Oral, oropharynx and hypopharynx (C00-C14)\n* Laryngreal cancer (C32)\n* \\*Esophageal cancer if possible (C15)\n\nExclusion Criteria:\n\n* Salivary gland (C07-C08)\n* Nasopharynx (C11)\n* Thyroid (C79.3)'}, 'identificationModule': {'nctId': 'NCT01972802', 'acronym': 'InterCHANGE', 'briefTitle': 'International Cancer of the Head and Neck, Genetics and Environment (InterCHANGE) Study', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'International Cancer of the Head and Neck, Genetics and Environment (InterCHANGE) Study', 'orgStudyIdInfo': {'id': '201006077R'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Tiapei', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pei-Jen Lou', 'role': 'CONTACT', 'email': 'pjlou@ntu.edu.tw', 'phone': '(02)23123456', 'phoneExt': '65224'}, {'name': 'Pei-Jen Lou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital'}], 'centralContacts': [{'name': 'Pei-Jen Lou', 'role': 'CONTACT', 'email': 'pjlou@ntu.edu.tw', 'phone': '+886-23123456', 'phoneExt': '65224'}], 'overallOfficials': [{'name': 'Pei-Jen Lou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}