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

April 14, 2024 updated by: Beijing Stomatological Hospital

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

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhien Feng, M.D., Ph.D.
  • Phone Number: 86-10-57099150
  • Email: jyfzhen@126.com

Study Contact Backup

  • Name: Dian Can Wang, M.D.
  • Phone Number: 86-10-62179977
  • Email: bjwdc@sina.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Zhen Wang, Ph.D.
      • Beijing, Beijing, China, 100038
        • Recruiting
        • Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Xiaolei Liu, Ph.D.
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Stomatological Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Zhien Feng, M.D.
      • Beijing, Beijing, China, 100081
        • Recruiting
        • School of Stomatology, Peking University
        • Contact:
          • Dian Can Wang, M.D.
          • Phone Number: 86-10-62179977
          • Email: bjwdc@sina.com
        • Principal Investigator:
          • Dian Can Wang, M.D.
      • Beijing, Beijing, China, 100043
        • Recruiting
        • Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Tiancheng Li, M.D.
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Department of Oral and Maxillofacial Surgery, First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Principal Investigator:
          • Qiang Sun, Ph.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Department of Oral and Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wei Cao, Ph.D.
        • Principal Investigator:
          • Xu Wang, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-specific survival
Time Frame: 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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor recurrence
Time Frame: 5 years
Tumor recurrence was defined as local recurrence postoperatively.
5 years
neck recurrence
Time Frame: 5 years
Neck recurrence was defined as regional recurrence whether was associated with local recurrence and distant metastasis or not.
5 years
multiple primary carcinomas
Time Frame: 5 years
The multiple primary carcinomas include second primary carcinoma and multiple synchronous primary cancers.
5 years
distant metastasis
Time Frame: 5 years
5 years
postoperative change from Baseline in quality of life score (UW-QOL questionnaire)
Time Frame: 1-5 years
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)
Time Frame: 1-5 years
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
Time Frame: 10 days; 42 days; 90 days
The postoperative complications were evaluated according to the Clavien-Dindo classification and the Accordion classification.
10 days; 42 days; 90 days
preoperative comorbidity
Time Frame: 1-5 years
The preoperative comorbidity was evaluated using Adult Comorbidity Evaluation -27 (ACE-27,Chinese Version).
1-5 years
delay time of cancer diagnosis
Time Frame: 0-2 years
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
Time Frame: 10 years
The complications of postoperative radiotherapy
10 years
The correlation among cancer family history, carcinogenesis and prognosis
Time Frame: 10 years
The carcinogenesis and prognostic role of family history in patients with head and neck malignancies
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Stomatological Hospital

Collaborators

Beijing Friendship Hospital
Beijing Chao Yang Hospital
The First Affiliated Hospital of Zhengzhou University
Peking University Hospital of Stomatology
Beijing Shijitan Hospital of 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

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)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeiSH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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