Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT02395367
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Observational, Real-world Oral Malignant Tumors Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018714', 'term': 'Radiotherapy, Adjuvant'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Investigators plan to retrieve the fresh and paraffin-embedded tissue specimens after primary tumors are resected from the biobank in all of the centers during the whole study phase. The total number of fresh and paraffin-embedded tissue specimens are approximately 30000. Specimen types include non-cancerous matched tissues and cancer tissues. These specimens will be used to complete the analysis of genetics and epigenetics in the further study. And samples of blood and saliva are also collected.Investigators plan to draw fresh blood and saliva sample from patients treated in the departments. Biomarkers of saliva, plasma separation and DNA samples of whole blood will be used for further translational medicine study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2015-03-20', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-specific survival', 'timeFrame': '5 years', 'description': 'Disease-specific survival was calculated as the time from the first operation to the time of death or last follow-up; patients who died from causes other than oral and maxillofacial cancer were defined as survivors at the time of death.'}], 'secondaryOutcomes': [{'measure': 'tumor recurrence', 'timeFrame': '5 years', 'description': 'Tumor recurrence was defined as local recurrence postoperatively.'}, {'measure': 'neck recurrence', 'timeFrame': '5 years', 'description': 'Neck recurrence was defined as regional recurrence whether was associated with local recurrence and distant metastasis or not.'}, {'measure': 'multiple primary carcinomas', 'timeFrame': '5 years', 'description': 'The multiple primary carcinomas include second primary carcinoma and multiple synchronous primary cancers.'}, {'measure': 'distant metastasis', 'timeFrame': '5 years'}, {'measure': 'postoperative change from Baseline in quality of life score (UW-QOL questionnaire)', 'timeFrame': '1-5 years', 'description': 'The comparison between preoperative and postoperative quality of life score using UW-QOL questionnaire.'}, {'measure': 'postoperative change from Baseline in anxiety and depression (Hospital Anxiety and Depression Scale, and Distress Thermometer)', 'timeFrame': '1-5 years', 'description': 'The comparison between preoperative and postoperative score of anxiety and depression using "Hospital Anxiety and Depression Scale" and "Distress Thermometer".'}, {'measure': 'postoperative complications', 'timeFrame': '10 days; 42 days; 90 days', 'description': 'The postoperative complications were evaluated according to the Clavien-Dindo classification and the Accordion classification.'}, {'measure': 'preoperative comorbidity', 'timeFrame': '1-5 years', 'description': 'The preoperative comorbidity was evaluated using Adult Comorbidity Evaluation -27 (ACE-27,Chinese Version).'}, {'measure': 'delay time of cancer diagnosis', 'timeFrame': '0-2 years', 'description': 'The delay time of cancer diagnosis was calculated as the time from the chief complaint to the pathological diagnosis.'}, {'measure': 'Radiotherapy relative complications', 'timeFrame': '10 years', 'description': 'The complications of postoperative radiotherapy'}, {'measure': 'The correlation among cancer family history, carcinogenesis and prognosis', 'timeFrame': '10 years', 'description': 'The carcinogenesis and prognostic role of family history in patients with head and neck malignancies'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prognosis', 'Risk Factors'], 'conditions': ['Head and Neck Neoplasms', 'Quality of Life', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '36239788', 'type': 'DERIVED', 'citation': 'Xiong L, Yu H, Wei W, Wang C, Li B, Liu H, Cheng A, Li D, Han Z, Feng Z. Chemotherapy for primary cancer can reduce the risk of head and neck second primary malignancy: a propensity-matched analysis. Clin Oral Investig. 2023 Feb;27(2):571-580. doi: 10.1007/s00784-022-04752-y. Epub 2022 Oct 14.'}, {'pmid': '35883131', 'type': 'DERIVED', 'citation': 'Zhu Y, Li B, Liu H, Li D, Cheng A, Wang C, Han Z, Feng Z. Prognostic factors and related complications/sequalae of squamous cell carcinoma located in the gingivobuccal complex. World J Surg Oncol. 2022 Jul 26;20(1):240. doi: 10.1186/s12957-022-02708-w.'}, {'pmid': '30926067', 'type': 'DERIVED', 'citation': 'Mao MH, Wang S, Feng ZE, Li JZ, Li H, Qin LZ, Han ZX. Accuracy of magnetic resonance imaging in evaluating the depth of invasion of tongue cancer. A prospective cohort study. Oral Oncol. 2019 Apr;91:79-84. doi: 10.1016/j.oraloncology.2019.01.021. Epub 2019 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to construct a register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in north Chinese population.', 'detailedDescription': 'A register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in Chinese population was absent.\n\nThe aim of the study is to construct a register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in Chinese population. The variables in the study include social informatics, etiology, and psychological and quality of life, coexistence disease, baseline clinicopathological data, postoperative complications, and long-term follow-up results.\n\nBy released annual analysis report, the epidemiological features and prognostic factors of oral and maxillofacial malignant tumors in north Chinese population can be identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients with previously untreated oral and maxillofacial malignant tumors were scheduled for radical surgery in Beijing stomatological hospital of Capital Medical University, Beijing Shijitan Hospital of Capital Medical University, stomatological hospital of Peking University, Beijing Friendship Hospital, First Affiliated Hospital of Zhengzhou University, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, and Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histological diagnosis of oral and maxillofacial malignant tumors\n* no previous treatment\n* a primary tumor without distant metastasis evidence\n* sites: lip, tongue, buccal mucosa, upper and lower gingiva, floor of the mouth, hard palate, oropharynx, salivary gland, upper and lower jaw, and maxillary sinus\n\nExclusion Criteria:\n\n* patients decline to participate the study\n* refusal or inability to receive definitive treatment for the disease\n* recurrent tumors'}, 'identificationModule': {'nctId': 'NCT02395367', 'acronym': 'POROMS', 'briefTitle': 'Prospective, Observational, Real-world Oral Malignant Tumors Study', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Stomatological Hospital, Capital Medical University'}, 'officialTitle': 'A Prospective, Observational, Real-world Study Based on the Register System of Oral and Maxillofacial Malignant Tumors', 'orgStudyIdInfo': {'id': 'BeiSH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'resection', 'type': 'PROCEDURE', 'description': 'This is an observational study. And we are interested in observing the outcome of different treatment methods.'}, {'name': 'adjuvant radiotherapy', 'type': 'RADIATION', 'description': 'This is an observational study. And we are interested in observing the outcome of different treatment methods.'}, {'name': 'neoadjuvant chemotherapy or adjuvant chemotherapy', 'type': 'DRUG', 'description': 'This is an observational study. And we are interested in observing the outcome of different treatment methods.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100043', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Stomatological Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100081', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'School of Stomatology, Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Department of Oral and Maxillofacial Surgery, First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Department of Oral and Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhien Feng, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oral and Maxillofacial-Head and Neck Oncology, Beijing Stomatological Hospital, Capital Medical University.'}, {'name': 'Dian-can Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oral and Maxillofacial Surgery, School of Stomatology Peking University.'}, {'name': 'Xiaolei Liu, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University'}, {'name': 'Zhen Wang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Friendship Hospital, Capital Medical Universiy'}, {'name': 'Wei Cao, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine"}, {'name': 'Qiang Sun, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}, {'name': 'Xu Wang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine"}, {'name': 'Tiancheng Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Stomatological Hospital, Capital Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Hospital of Stomatology', 'class': 'OTHER'}, {'name': 'Beijing Shijitan Hospital, Capital Medical University', 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': "Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine", 'class': 'UNKNOWN'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}