Head and Neck Neoplasms, Postoperative Complications, Quality of Life
Conditions
Keywords
Prognosis, Risk Factors
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.
Interventions
PROCEDUREresection
This is an observational study. And we are interested in observing the outcome of different treatment methods.
RADIATIONadjuvant radiotherapy
This is an observational study. And we are interested in observing the outcome of different treatment methods.
DRUGneoadjuvant chemotherapy or adjuvant chemotherapy
This is an observational study. And we are interested in observing the outcome of different treatment methods.
Sponsors
Peking University Hospital of Stomatology
Beijing Shijitan Hospital, Capital Medical University
Beijing Friendship Hospital
The First Affiliated Hospital of Zhengzhou University
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Beijing Chao Yang Hospital
Beijing Stomatological Hospital, Capital Medical University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| tumor recurrence | 5 years | Tumor recurrence was defined as local recurrence postoperatively. |
| 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 |
| postoperative complications | 10 days; 42 days; 90 days | The postoperative complications were evaluated according to the Clavien-Dindo classification and the Accordion classification. |
Countries
China
Outcome results
None listed