Prospective, Observational, Real-world Oral Malignant Tumors Study

Beijing Stomatological Hospital, Capital Medical University30,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

30,000

Conditions

Head and Neck Neoplasms Quality of Life Postoperative Complications

Interventions

resectionPROCEDURE

This is an observational study. And we are interested in observing the outcome of different treatment methods.

adjuvant radiotherapyRADIATION

This is an observational study. And we are interested in observing the outcome of different treatment methods.

neoadjuvant chemotherapy or adjuvant chemotherapyDRUG

This is an observational study. And we are interested in observing the outcome of different treatment methods.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (7)

Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

tumor recurrence

Tumor recurrence was defined as local recurrence postoperatively.

Time frame: 5 years

neck recurrence

Neck recurrence was defined as regional recurrence whether was associated with local recurrence and distant metastasis or not.

Time frame: 5 years

multiple primary carcinomas

The multiple primary carcinomas include second primary carcinoma and multiple synchronous primary cancers.

Time frame: 5 years

distant metastasis

Time frame: 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.

Time frame: 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".

Time frame: 1-5 years

Data from ClinicalTrials.gov

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