Prospective, Observational, Real-world Oral Malignant Tumors Study

Study Overview
=================
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.

Detailed Description
-----------------
A register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in 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.

Official Title
-----------------
A Prospective, Observational, Real-world Study Based on the Register System of Oral and Maxillofacial Malignant Tumors

Conditions
-----------------
Head and Neck Neoplasms, Quality of Life, Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: resection
* Radiation: adjuvant radiotherapy
* Drug: neoadjuvant chemotherapy or adjuvant chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological diagnosis of oral and maxillofacial malignant tumors no previous treatment a primary tumor without distant metastasis evidence 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: patients decline to participate the study refusal or inability to receive definitive treatment for the disease recurrent tumors
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: resection|This is an observational study. And we are interested in observing the outcome of different treatment methods.|
|Radiation: adjuvant radiotherapy|This is an observational study. And we are interested in observing the outcome of different treatment methods.|
|Drug: neoadjuvant chemotherapy or adjuvant chemotherapy|This is an observational study. And we are interested in observing the outcome of different treatment methods.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-specific survival | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor recurrence | Tumor recurrence was defined as local recurrence postoperatively. | 5 years | 
| neck recurrence | Neck recurrence was defined as regional recurrence whether was associated with local recurrence and distant metastasis or not. | 5 years | 
| multiple primary carcinomas | The multiple primary carcinomas include second primary carcinoma and multiple synchronous primary cancers. | 5 years | 
| distant metastasis |  | 5 years | 
| postoperative change from Baseline in quality of life score (UW-QOL questionnaire) | The comparison between preoperative and postoperative quality of life score using UW-QOL questionnaire. | 1-5 years | 
| postoperative change from Baseline in anxiety and depression (Hospital Anxiety and Depression Scale, and Distress Thermometer) | The comparison between preoperative and postoperative score of anxiety and depression using Hospital Anxiety and Depression Scale and Distress Thermometer. | 1-5 years | 
| postoperative complications | The postoperative complications were evaluated according to the Clavien-Dindo classification and the Accordion classification. | 10 days; 42 days; 90 days | 
| preoperative comorbidity | The preoperative comorbidity was evaluated using Adult Comorbidity Evaluation -27 (ACE-27,Chinese Version). | 1-5 years | 
| delay time of cancer diagnosis | The delay time of cancer diagnosis was calculated as the time from the chief complaint to the pathological diagnosis. | 0-2 years | 
| Radiotherapy relative complications | The complications of postoperative radiotherapy | 10 years | 
| The correlation among cancer family history, carcinogenesis and prognosis | The carcinogenesis and prognostic role of family history in patients with head and neck malignancies | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognosis, Risk Factors