Prospective, Observational, Real-world Oral Malignant Tumors Study

Completed

• Conditions: Quality of Life; Head and Neck Neoplasms; Postoperative Complications

• Registration Number: NCT02395367
• Lead Sponsor: Beijing Stomatological Hospital, Capital Medical University

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-23
• Status Verified: 2025-03
• Primary Completion: 2025-03
• Study Completion: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
postoperative complications	10 days; 42 days; 90 days	The postoperative complications were evaluated according to the Clavien-Dindo classification and the Accordion classification.
multiple primary carcinomas	5 years	The multiple primary carcinomas include second primary carcinoma and multiple synchronous primary cancers.
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".
preoperative comorbidity	1-5 years	The preoperative comorbidity was evaluated using Adult Comorbidity Evaluation -27 (ACE-27,Chinese Version).
Radiotherapy relative complications	10 years	The complications of postoperative radiotherapy
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.
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.
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.
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
distant metastasis	5 years

Trial Locations

Locations (7)

Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Stomatological Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

School of Stomatology, Peking University; 🇨🇳 Beijing, Beijing, China

Department of Oral and Maxillofacial Surgery, First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Department of Oral and Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China