Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-30 @ 3:03 AM
Study NCT ID:
NCT02546895
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2015-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Registration of Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Serum\n2. Tissue specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '3 years', 'description': 'Revised RECIST guideline'}], 'secondaryOutcomes': [{'measure': 'Identification of biomarkers of clinical significance (prognostic)', 'timeFrame': '5 years', 'description': 'Biomarkers associated with treatment outcomes (HPV, Epidermal growth factor receptor, p53, p16, etc)'}, {'measure': 'Number of participants with treatment-related morbidity', 'timeFrame': '5 years', 'description': 'CTCAE protocol'}, {'measure': 'Number of participants with treatment response', 'timeFrame': '5 years', 'description': 'Number of participants with treatment response'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Revised RECIST guideline'}, {'measure': 'Scores of distress questionnaire', 'timeFrame': '1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment', 'description': 'QLQ HN43'}, {'measure': 'Scores of support survey', 'timeFrame': '1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment', 'description': 'QLQ HN43'}, {'measure': 'Quality of life score', 'timeFrame': '1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment', 'description': 'QLQ HN43'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['head and neck cancer patients', 'clinical data', 'tissue collection', 'prospective registration', 'patients'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '21160525', 'type': 'BACKGROUND', 'citation': 'Leemans CR, Braakhuis BJ, Brakenhoff RH. The molecular biology of head and neck cancer. Nat Rev Cancer. 2011 Jan;11(1):9-22. doi: 10.1038/nrc2982. Epub 2010 Dec 16.'}, {'pmid': '16467544', 'type': 'BACKGROUND', 'citation': 'Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.'}, {'pmid': '17960013', 'type': 'BACKGROUND', 'citation': 'Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.'}, {'pmid': '17327856', 'type': 'BACKGROUND', 'citation': 'Seiwert TY, Salama JK, Vokes EE. The chemoradiation paradigm in head and neck cancer. Nat Clin Pract Oncol. 2007 Mar;4(3):156-71. doi: 10.1038/ncponc0750.'}, {'pmid': '17259930', 'type': 'BACKGROUND', 'citation': 'Seiwert TY, Salama JK, Vokes EE. The concurrent chemoradiation paradigm--general principles. Nat Clin Pract Oncol. 2007 Feb;4(2):86-100. doi: 10.1038/ncponc0714.'}, {'pmid': '17960012', 'type': 'BACKGROUND', 'citation': 'Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.'}, {'pmid': '18474878', 'type': 'BACKGROUND', 'citation': "Kumar B, Cordell KG, Lee JS, Worden FP, Prince ME, Tran HH, Wolf GT, Urba SG, Chepeha DB, Teknos TN, Eisbruch A, Tsien CI, Taylor JM, D'Silva NJ, Yang K, Kurnit DM, Bauer JA, Bradford CR, Carey TE. EGFR, p16, HPV Titer, Bcl-xL and p53, sex, and smoking as indicators of response to therapy and survival in oropharyngeal cancer. J Clin Oncol. 2008 Jul 1;26(19):3128-37. doi: 10.1200/JCO.2007.12.7662. Epub 2008 May 12."}, {'pmid': '19446902', 'type': 'BACKGROUND', 'citation': 'Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14.'}, {'pmid': '16275937', 'type': 'BACKGROUND', 'citation': 'Hitt R, Lopez-Pousa A, Martinez-Trufero J, Escrig V, Carles J, Rizo A, Isla D, Vega ME, Marti JL, Lobo F, Pastor P, Valenti V, Belon J, Sanchez MA, Chaib C, Pallares C, Anton A, Cervantes A, Paz-Ares L, Cortes-Funes H. Phase III study comparing cisplatin plus fluorouracil to paclitaxel, cisplatin, and fluorouracil induction chemotherapy followed by chemoradiotherapy in locally advanced head and neck cancer. J Clin Oncol. 2005 Dec 1;23(34):8636-45. doi: 10.1200/JCO.2004.00.1990. Epub 2005 Nov 7.'}, {'pmid': '19897418', 'type': 'BACKGROUND', 'citation': 'Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. doi: 10.1016/S1470-2045(09)70311-0. Epub 2009 Nov 10.'}, {'type': 'BACKGROUND', 'citation': 'Hah, J. H. (2012). Personalized Treatment of Head and Neck Cancers and the Role of Head and Neck Surgeons. Korean Journal of Otorhinolaryngology-Head and Neck Surgery, 55(8), 471-475'}, {'pmid': '11896109', 'type': 'BACKGROUND', 'citation': 'Glisson BS, Murphy BA, Frenette G, Khuri FR, Forastiere AA. Phase II Trial of docetaxel and cisplatin combination chemotherapy in patients with squamous cell carcinoma of the head and neck. J Clin Oncol. 2002 Mar 15;20(6):1593-9. doi: 10.1200/JCO.2002.20.6.1593.'}, {'pmid': '36512301', 'type': 'DERIVED', 'citation': 'Kang D, Kim E, Choi N, Kim H, Cho J, Jeong HS. Pre-treatment quality of life in patients with salivary gland cancer in comparison with those of head and neck cancer patients. Qual Life Res. 2023 May;32(5):1493-1506. doi: 10.1007/s11136-022-03323-8. Epub 2022 Dec 13.'}]}, 'descriptionModule': {'briefSummary': "Head and neck cancers account for the sixth leading cause of cancers worldwide. The annual incidence of Head and neck cancers is more than 650,000 the patients each year. Head and neck cancers are associated with smoking, alcohol consumption, human papilloma virus (type 16 and 18) and previous exposure to radiation.\n\nSo far, most of clinical and research data about head and neck cancers, such as the etiology, pathogenesis, prognosis factors and associated factors, treatment outcomes, are from Western countries. However, due to various environmental factors, for example race, genetics, geographical factors, general hygiene and health care system differences, the possibility of differences of disease characteristics between Western and Asian people should be considered.\n\nFor several decades, there have been many studies about treatment modalities (surgery, chemotherapy, and radiation therapy), complications and side effects for head and neck cancers in the West. Many institutions tried to improve the survival rate and resolve the toxicity of chemotherapy and radiation treatment for head and neck cancer patients. However there has been little information about the characteristics of head and neck cancers, effectiveness of treatment (survival rate, recurrence, and complication rate), and prognosis, particularly in Korean as well as in Asian patients.\n\nTherefore it is necessary to evaluate and analyze the features of head and neck cancers such as etiology, pathogenesis, risk factors, prognostic factors, treatment outcomes in a site specific cohort (South Korea) separately. It could be helpful to improve the treatment outcomes of head and neck cancers overall, to design race or site specific treatments for head and neck cancers, and to develop management strategy common in Asia as well as the West.\n\nThe purpose of this study is\n\n1. To establish the prospective tumor registry about patient's information, treatment-related morbidities, treatment outcomes and quality of life, in addition to the prospective collection of patient samples (blood and tumor tissues).\n2. To establish the predictive model for treatment outcomes and treatment-related morbidities.\n3. To develop the biomarkers as predictive and/or prognostic factors.", 'detailedDescription': 'Review of medical records Medical records of enrolled patients will be reviewed to evaluate clinical characteristics, treatment-related adverse events, time to progression and overall survival.\n\nBehavioral : Questionnaires 3 times : Prior to the 1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment Other Names : Surveys'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pathologically proven head and neck cancer patients, who are referred to Samsung Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over 19 years-old\n* Patients diagnosed as head and neck cancer histopathologically according to American Joint Committee on Cancer, Cancer staging manual, 7th edition at Samsung Medical Center:\n\n * Comprise a part of head and neck\n * Oral cavity\n * Pharynx\n * Larynx\n * Hypopharynx\n * Nasal cavity\n * Paranasal sinus\n * Nasopharynx\n * Salivary gland\n * Skin in the head and neck\n* In case patients are diagnosed at other hospitals, it can be possible to register the tissue of cancer cell with Samsung medical center and confirm the diagnosis by pathologists of Samsung medical center.\n* Histopathological type:\n\n * Squamous cell carcinoma\n * Malignant melanoma\n * Sarcoma and other carcinomas are included.\n* Metastasis of Unknown Origin (MUO) at head and neck is included.\n* Patients who receive a proper treatment as scheduled.\n* Informed consents: patients who understand the purpose of study and are capable of giving a written consent.\n\nExclusion criteria:\n\n* Patients who do not meet the requirements of inclusion criteria'}, 'identificationModule': {'nctId': 'NCT02546895', 'briefTitle': 'Prospective Registration of Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prospective Registration of Head and Neck Cancer Patients for Clinical Data and Tissue Collection', 'orgStudyIdInfo': {'id': '2015-06-132'}}, 'armsInterventionsModule': {'interventions': [{'name': 'chart review', 'type': 'OTHER', 'otherNames': ['surveys'], 'description': 'The patient charts will be reviewed to determine pretreatment characteristics, treatment-related adverse events, time to progression and overall survival.\n\nBehavioral: Questionnaires Completion of 3 questionnaires 1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment. It may take about 30 minutes to complete the questionnaires each time.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun-Hye Kim, RN', 'role': 'CONTACT', 'email': 'eh0502.kim@samsung.com', 'phone': '82-2-3410-2034'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Han-Sin Jeong, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'hansin.jeong@samsung.com', 'phone': '82-2-3410-0291'}], 'overallOfficials': [{'name': 'Han-Sin Jeong, M.D.Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center'}, {'name': 'Se-Hoon Lee, M.D.Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center'}, {'name': 'Dongryul Oh, M.D.Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center'}, {'name': 'Chung-Hwan Baek, M.D.Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center'}, {'name': 'Young-Ik Son, M.D.Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center'}, {'name': 'Man Ki Chung, M.D.Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center'}, {'name': 'Young Chan Ahn, M.D.Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Radiation Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center'}, {'name': 'Myung-Ju Ahn, M.D.Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center'}, {'name': 'Keunchil Park, M.D.Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Hemato-Oncology, Sungkyunkwan University School of Medicine, Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Han-Sin Jeong', 'investigatorAffiliation': 'Samsung Medical Center'}}}}