Prospective, Observational, Real-world Oral Malignant Tumors Study (POROMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Postoperative Complications; Head and Neck Neoplasms
• Intervention / Treatment: Procedure: resection; Radiation: adjuvant radiotherapy; Drug: neoadjuvant chemotherapy or adjuvant chemotherapy

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 Type: Observational
• Enrollment (Estimated): 30000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 100038
      • Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University
    • Beijing, Beijing, China, 100043
      • Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University
    • Beijing, Beijing, China, 100050
      • Beijing Stomatological Hospital, Capital Medical University
    • Beijing, Beijing, China, 100081
      • School of Stomatology, Peking University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Department of Oral and Maxillofacial Surgery, First Affiliated Hospital of Zhengzhou University
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Department of Oral and Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: Beijing Stomatological Hospital, Capital Medical University
• Collaborators: Beijing Friendship Hospital; Beijing Chao Yang Hospital; The First Affiliated Hospital of Zhengzhou University; Peking University Hospital of Stomatology; Beijing Shijitan Hospital, Capital Medical University; Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Zhien Feng, M.D., Ph.D., Department of Oral and Maxillofacial-Head and Neck Oncology, Beijing Stomatological Hospital, Capital Medical University.; Principal Investigator: Dian-can Wang, M.D., Department of Oral and Maxillofacial Surgery, School of Stomatology Peking University.; Principal Investigator: Xiaolei Liu, Ph.D., Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University; Principal Investigator: Zhen Wang, Ph.D., Beijing Friendship Hospital, Capital Medical Universiy; Principal Investigator: Wei Cao, Ph.D., Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; Principal Investigator: Qiang Sun, Ph.D., The First Affiliated Hospital of Zhengzhou University; Principal Investigator: Xu Wang, Ph.D., Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; Principal Investigator: Tiancheng Li, M.D., Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (Estimated): March 23, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Prognosis; Risk Factors
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Postoperative Complications
• Other Study ID Numbers: BeiSH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No