Clinical trial NCT02395367: Prospective, Observational, Real-world Oral Malignant Tumors Study
Official title: A Prospective, Observational, Real-world Study Based on the Register System of Oral and Maxillofacial Malignant Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasms
Quality of Life
Postoperative Complications
Keywords: Prognosis
Risk Factors
Lead sponsor: Beijing Stomatological Hospital, Capital Medical University
Sponsor class: OTHER
Collaborators: name: Peking University Hospital of Stomatology
name: Beijing Shijitan Hospital, Capital Medical University
name: Beijing Friendship Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
name: Beijing Chao Yang Hospital
First posted: 2015-03-23
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with previously untreated oral and maxillofacial malignant tumors were scheduled for radical surgery in Beijing stomatological hospital of Capital Medical University, Beijing Shijitan Hospital of Capital Medical University, stomatological hospital of Peking University, Beijing Friendship Hospital, First Affiliated Hospital of Zhengzhou University, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, and Department of Otolaryngology, Beijing Chaoyang 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.

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

Primary outcomes:
measure: disease-specific survival
timeFrame: 5 years
Secondary outcomes:
measure: tumor recurrence
timeFrame: 5 years
measure: neck recurrence
timeFrame: 5 years
measure: multiple primary carcinomas
timeFrame: 5 years
measure: distant metastasis
timeFrame: 5 years
measure: postoperative change from Baseline in quality of life score (UW-QOL questionnaire)
timeFrame: 1-5 years
measure: postoperative change from Baseline in anxiety and depression (Hospital Anxiety and Depression Scale, and Distress Thermometer)
timeFrame: 1-5 years
measure: postoperative complications
timeFrame: 10 days; 42 days; 90 days
measure: preoperative comorbidity
timeFrame: 1-5 years
measure: delay time of cancer diagnosis
timeFrame: 0-2 years
measure: Radiotherapy relative complications
timeFrame: 10 years
measure: The correlation among cancer family history, carcinogenesis and prognosis
timeFrame: 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Stomatological Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: School of Stomatology, Peking University
state: Beijing
city: Zhengzhou
country: China
facility: Department of Oral and Maxillofacial Surgery, First Affiliated Hospital of Zhengzhou University
state: Henan
city: Shanghai
country: China
facility: Department of Oral and Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Department of Oral and Maxillofacial-Head and Neck Oncology, Beijing Stomatological Hospital, Capital Medical University.
name: Zhien Feng, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oral and Maxillofacial Surgery, School of Stomatology Peking University.
name: Dian-can Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University
name: Xiaolei Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital, Capital Medical Universiy
name: Zhen Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
name: Wei Cao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Qiang Sun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
name: Xu Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University
name: Tiancheng Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xiong L, Yu H, Wei W, Wang C, Li B, Liu H, Cheng A, Li D, Han Z, Feng Z. Chemotherapy for primary cancer can reduce the risk of head and neck second primary malignancy: a propensity-matched analysis. Clin Oral Investig. 2023 Feb;27(2):571-580. doi: 10.1007/s00784-022-04752-y. Epub 2022 Oct 14.
citation: Zhu Y, Li B, Liu H, Li D, Cheng A, Wang C, Han Z, Feng Z. Prognostic factors and related complications/sequalae of squamous cell carcinoma located in the gingivobuccal complex. World J Surg Oncol. 2022 Jul 26;20(1):240. doi: 10.1186/s12957-022-02708-w.
citation: Mao MH, Wang S, Feng ZE, Li JZ, Li H, Qin LZ, Han ZX. Accuracy of magnetic resonance imaging in evaluating the depth of invasion of tongue cancer. A prospective cohort study. Oral Oncol. 2019 Apr;91:79-84. doi: 10.1016/j.oraloncology.2019.01.021. Epub 2019 Mar 4.