POROMS: Prospective, Observational, Real-world Oral Malignant Tumors Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
A register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in north Chinese population was absent.
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 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.
By released annual analysis report, the epidemiological features and prognostic factors of oral and maxillofacial malignant tumors in north Chinese population can be identified.
Study Design
Outcome Measures
Primary Outcome Measures
- disease-specific survival [5 years]
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.
Secondary Outcome Measures
- tumor recurrence [5 years]
Tumor recurrence was defined as local recurrence postoperatively.
- neck recurrence [5 years]
Neck recurrence was defined as regional recurrence whether was associated with local recurrence and distant metastasis or not.
- multiple primary carcinomas [5 years]
The multiple primary carcinomas include second primary carcinoma and multiple synchronous primary cancers.
- distant metastasis [5 years]
- postoperative change from Baseline in quality of life score (UW-QOL questionnaire) [1-5 years]
The comparison between preoperative and postoperative quality of life score using UW-QOL questionnaire.
- postoperative change from Baseline in anxiety and depression (Hospital Anxiety and Depression Scale, and Distress Thermometer) [1-5 years]
The comparison between preoperative and postoperative score of anxiety and depression using "Hospital Anxiety and Depression Scale" and "Distress Thermometer".
- postoperative complications [10 days; 42 days; 90 days]
The postoperative complications were evaluated according to the Clavien-Dindo classification and the Accordion classification.
- preoperative comorbidity [1-5 years]
The preoperative comorbidity was evaluated using Adult Comorbidity Evaluation -27 (ACE-27,Chinese Version).
- delay time of cancer diagnosis [0-2 years]
The delay time of cancer diagnosis was calculated as the time from the chief complaint to the pathological diagnosis.
- Radiotherapy relative complications [10 years]
The complications of postoperative radiotherapy
- The correlation among cancer family history, carcinogenesis and prognosis [10 years]
The carcinogenesis and prognostic role of family history in patients with head and neck malignancies
Eligibility Criteria
Criteria
Inclusion Criteria:
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histological diagnosis of oral and maxillofacial malignant tumors
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no previous treatment
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a primary tumor without distant metastasis evidence
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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
Exclusion Criteria:
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patients decline to participate the study
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refusal or inability to receive definitive treatment for the disease
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recurrent tumors
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University | Beijing | Beijing | China | 100038 |
| 2 | Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing | China | 100050 |
| 3 | Beijing Stomatological Hospital, Capital Medical University | Beijing | Beijing | China | 100050 |
| 4 | School of Stomatology, Peking University | Beijing | Beijing | China | 100081 |
| 5 | Department of Oral and Maxillofacial Surgery, First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | 450052 |
| 6 | Department of Oral and Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 200011 |
Sponsors and Collaborators
- Beijing Stomatological Hospital
- Peking University Hospital of Stomatology
- Beijing Shijitan Hospital of Capital Medical University
- Beijing Friendship Hospital
- The First Affiliated Hospital of Zhengzhou University
- Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
- Principal Investigator: Zhien Feng, M.D., Ph.D., Department of Oral and Maxillofacial-Head and Neck Oncology, Beijing Stomatological Hospital, Capital Medical University.
- Principal Investigator: Dian-can Wang, M.D., Department of Oral and Maxillofacial Surgery, School of Stomatology Peking University.
- Principal Investigator: Xiaolei Liu, Ph.D., Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University
- Principal Investigator: Zhen Wang, Ph.D., Beijing Friendship Hospital, Capital Medical Universiy
- Principal Investigator: Wei Cao, Ph.D., Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Principal Investigator: Qiang Sun, Ph.D., The First Affiliated Hospital of Zhengzhou University
- Principal Investigator: Xu Wang, Ph.D., Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BeiSH