Prospective, Observational, Real-world Oral Malignant Tumors Study

NCT ID: NCT02395367

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Neoplasms Quality of Life Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

resection

This is an observational study. And we are interested in observing the outcome of different treatment methods.

Intervention Type PROCEDURE

adjuvant radiotherapy

This is an observational study. And we are interested in observing the outcome of different treatment methods.

Intervention Type RADIATION

neoadjuvant chemotherapy or adjuvant chemotherapy

This is an observational study. And we are interested in observing the outcome of different treatment methods.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University Hospital of Stomatology

OTHER

Sponsor Role collaborator

Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

UNKNOWN

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Beijing Stomatological Hospital, Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhien Feng, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Oral and Maxillofacial-Head and Neck Oncology, Beijing Stomatological Hospital, Capital Medical University.

Dian-can Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Oral and Maxillofacial Surgery, School of Stomatology Peking University.

Xiaolei Liu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University

Zhen Wang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital, Capital Medical Universiy

Wei Cao, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Qiang Sun, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Xu Wang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Tiancheng Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing Stomatological Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

School of Stomatology, Peking University

Beijing, Beijing Municipality, China

Site Status

Department of Oral and Maxillofacial Surgery, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36239788 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35883131 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30926067 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BeiSH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prospective Observational Cohort Study
NCT06493448 NOT_YET_RECRUITING