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

March 5, 2025 updated by: Beijing Stomatological Hospital, Capital Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Stomatological Hospital, Capital Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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