[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00898638":3,"trial-entities:NCT00898638":188,"trial-summary:NCT00898638":192},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":109,"primary_purpose":110,"phases":111,"enrollment_info":112,"interventions":115,"primary_outcomes":124,"secondary_outcomes":132,"sex":133,"minimum_age":134,"maximum_age":110,"healthy_volunteers":135,"eligibility_criteria":136,"std_ages":140,"locations":143,"central_contacts":178,"overall_officials":183,"references":186,"see_also_links":187},"NCT00898638","CDR0000546682","Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants","Head and Neck Tumor Tissue Repository and Clinical Database","RECRUITING","2050-12","2025-10","2025-10-28","2003-02-13","Vanderbilt University Medical Center","OTHER",false,"RATIONALE: Collecting and storing samples of tissue, saliva, and blood from patients with cancer and from healthy participants to study in the laboratory may help the study of cancer in the future.\n\nPURPOSE: This research study is collecting and storing tissue samples from patients with head and neck cancer and from healthy participants.","OBJECTIVES:\n\n* Maintain and update a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer.\n* Develop a repository of biospecimens from these patients.\n\nOUTLINE: Tumor tissue samples and\u002For bronchial washings are collected from patients undergoing planned surgery and\u002For bronchoscopy, respectively. Buccal swabs and\u002For mouthwash samples and saliva samples are collected. Patients also undergo blood sample collection at baseline and then every 2-6 months thereafter.\n\nHealthy participants contribute blood samples, buccal swabs, and mouthwash samples at baseline only.\n\nInformation about medical and family history and cancer risk factors is also collected.\n\nPROJECTED ACCRUAL: No limit.\n\nFOLLOW UP: Indefinite, until date of death or lost to follow up.",[19],"Head and Neck Cancer",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"stage I squamous cell carcinoma of the hypopharynx","stage II squamous cell carcinoma of the hypopharynx","stage III squamous cell carcinoma of the hypopharynx","stage IV squamous cell carcinoma of the hypopharynx","recurrent squamous cell carcinoma of the hypopharynx","stage I squamous cell carcinoma of the larynx","stage I verrucous carcinoma of the larynx","stage II squamous cell carcinoma of the larynx","stage II verrucous carcinoma of the larynx","stage III squamous cell carcinoma of the larynx","stage III verrucous carcinoma of the larynx","stage IV squamous cell carcinoma of the larynx","stage IV verrucous carcinoma of the larynx","recurrent squamous cell carcinoma of the larynx","recurrent verrucous carcinoma of the larynx","stage I adenoid cystic carcinoma of the oral cavity","stage I basal cell carcinoma of the lip","stage I mucoepidermoid carcinoma of the oral cavity","stage I squamous cell carcinoma of the lip and oral cavity","stage I verrucous carcinoma of the oral cavity","stage II adenoid cystic carcinoma of the oral cavity","stage II basal cell carcinoma of the lip","stage II mucoepidermoid carcinoma of the oral cavity","stage II squamous cell carcinoma of the lip and oral cavity","stage II verrucous carcinoma of the oral cavity","stage III adenoid cystic carcinoma of the oral cavity","stage III basal cell carcinoma of the lip","stage III mucoepidermoid carcinoma of the oral cavity","stage III squamous cell carcinoma of the lip and oral cavity","stage III verrucous carcinoma of the oral cavity","stage IV adenoid cystic carcinoma of the oral cavity","stage IV basal cell carcinoma of the lip","stage IV mucoepidermoid carcinoma of the oral cavity","stage IV squamous cell carcinoma of the lip and oral cavity","stage IV verrucous carcinoma of the oral cavity","recurrent adenoid cystic carcinoma of the oral cavity","recurrent basal cell carcinoma of the lip","recurrent mucoepidermoid carcinoma of the oral cavity","recurrent squamous cell carcinoma of the lip and oral cavity","recurrent verrucous carcinoma of the oral cavity","metastatic squamous neck cancer with occult primary squamous cell carcinoma","recurrent metastatic squamous neck cancer with occult primary","untreated metastatic squamous neck cancer with occult primary","stage I lymphoepithelioma of the nasopharynx","stage I squamous cell carcinoma of the nasopharynx","stage II lymphoepithelioma of the nasopharynx","stage II squamous cell carcinoma of the nasopharynx","stage III lymphoepithelioma of the nasopharynx","stage III squamous cell carcinoma of the nasopharynx","stage IV lymphoepithelioma of the nasopharynx","stage IV squamous cell carcinoma of the nasopharynx","recurrent lymphoepithelioma of the nasopharynx","recurrent squamous cell carcinoma of the nasopharynx","stage I lymphoepithelioma of the oropharynx","stage I squamous cell carcinoma of the oropharynx","stage II lymphoepithelioma of the oropharynx","stage II squamous cell carcinoma of the oropharynx","stage III lymphoepithelioma of the oropharynx","stage III squamous cell carcinoma of the oropharynx","stage IV lymphoepithelioma of the oropharynx","stage IV squamous cell carcinoma of the oropharynx","recurrent lymphoepithelioma of the oropharynx","stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity","stage I inverted papilloma of the paranasal sinus and nasal cavity","stage I midline lethal granuloma of the paranasal sinus and nasal cavity","stage I squamous cell carcinoma of the paranasal sinus and nasal cavity","stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity","stage II inverted papilloma of the paranasal sinus and nasal cavity","stage II midline lethal granuloma of the paranasal sinus and nasal cavity","stage II squamous cell carcinoma of the paranasal sinus and nasal cavity","stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity","stage III inverted papilloma of the paranasal sinus and nasal cavity","stage III midline lethal granuloma of the paranasal sinus and nasal cavity","stage III squamous cell carcinoma of the paranasal sinus and nasal cavity","stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity","stage IV inverted papilloma of the paranasal sinus and nasal cavity","stage IV midline lethal granuloma of the paranasal sinus and nasal cavity","stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity","recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity","recurrent inverted papilloma of the paranasal sinus and nasal cavity","recurrent midline lethal granuloma of the paranasal sinus and nasal cavity","recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity","stage I salivary gland cancer","stage II salivary gland cancer","stage III salivary gland cancer","stage IV salivary gland cancer","recurrent salivary gland cancer","recurrent squamous cell carcinoma of the oropharynx","OBSERVATIONAL",null,[],{"count":113,"type":114},8000,"ESTIMATED",[116,121],{"type":14,"name":117,"armGroupLabels":118},"biologic sample preservation procedure",[119,120],"Head and Neck Tumor patients","Healthy Volunteers",{"type":14,"name":122,"armGroupLabels":123},"medical chart review",[119,120],[125,129],{"measure":126,"description":127,"timeFrame":128},"Maintenance of a clinical database pertaining to diagnosis and treatment outcome of patients with head and neck cancer","Collection of data for both groups from the Vanderbilt Otolaryngology Patient Intake questionnaire as well as the medical record, such as medical history, family history, and exposures to risk factors for cancer (tobacco and alcohol use), and results of tests related to diagnosis of tumor and treatment response (for tumor patients only).","ongoing",{"measure":130,"description":131,"timeFrame":128},"Development of a repository of biospecimens","Collection of blood, tissue, saliva, bronchial washings and other specimens as indicated from both tumor and healthy patients.",[],"ALL","18 Years",true,{"inclusion":137,"exclusion":138,"raw_text":139},[],[],"DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n  * Diagnosis of head and neck cancer\n  * Being treated at Vanderbilt University Medical Center for the cancer\n  * Healthy participant\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified",[141,142],"ADULT","OLDER_ADULT",[144,158,163,171],{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":149,"contacts":150,"geoPoint":155},"Vanderbilt-Ingram Cancer Center - Cool Springs","Nashville","Tennessee","37064","United States",[151],{"name":152,"role":153,"phone":154},"Eben Rosenthal, MD","CONTACT","800-811-8480",{"lat":156,"lon":157},36.16589,-86.78444,{"facility":159,"status":8,"city":146,"state":147,"zip":148,"country":149,"contacts":160,"geoPoint":162},"Vanderbilt-Ingram Cancer Center at Franklin",[161],{"name":152,"role":153,"phone":154},{"lat":156,"lon":157},{"facility":164,"status":8,"city":146,"state":147,"zip":165,"country":149,"contacts":166,"geoPoint":170},"Veterans Affairs Medical Center - Nashville","37212",[167],{"name":168,"role":153,"phone":169},"Clinical Trials Office - Veterans Affairs Medical Center - Nas","615-327-4751",{"lat":156,"lon":157},{"facility":172,"status":8,"city":146,"state":147,"zip":173,"country":149,"contacts":174,"geoPoint":177},"Vanderbilt-Ingram Cancer Center","37232-6838",[175],{"name":176,"role":153,"phone":154},"Clinical Trials Office - Vanderbilt-Ingram Cancer Center",{"lat":156,"lon":157},[179],{"name":180,"role":153,"phone":181,"email":182},"Brandee Brown","615-936-4896","brandee.t.brown@vumc.org",[184],{"name":152,"affiliation":13,"role":185},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":189,"biomarkers":191},[190],"Malignant Head and Neck Neoplasm",[],{"nct_id":4,"found":135,"summary":193,"prompt_version":203},{"design":194,"status":195,"heading":196,"summary":197,"follow_up":198,"word_count":199,"commitments":200,"compensation":201,"drugs_mentioned":202},"This is an observational study, meaning participants are not given an intervention. It aims to enroll 8000 participants, including those with head and neck cancer and healthy individuals.","completed","Tissue Sample Collection for Head and Neck Cancer Research","This study is collecting and storing tissue, saliva, and blood samples from people with head and neck cancer and from healthy volunteers. Researchers believe that studying these samples in the lab can help us learn more about cancer in the future. If you have head and neck cancer and are being treated at Vanderbilt University Medical Center, or if you are a healthy adult, you might be able to join. The main goals are to create a database of information about head and neck cancer diagnosis and treatment, and to build a collection of these biological samples for future research. The study is currently ongoing.","Participants will be followed indefinitely, until date of death or if they are lost to follow up.",105,"If you have cancer, tumor tissue, bronchial washings, buccal swabs, mouthwash, saliva, and blood samples will be collected. Healthy participants will provide blood samples, buccal swabs, and mouthwash samples at the start. Information on medical history, family history, and cancer risk factors will also be collected.","Not stated in the trial record.",[],"v2"]