Prospective, Observational, Real-world Oral Malignant Tumors Study

NCT02395367 | Completed

• 1 other identifier: BeiSH
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 7

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.

Conditions

Head and Neck Neoplasms; Quality of Life; Postoperative Complications

Keywords

Prognosis; Risk Factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• tumor recurrence

  5 years

• neck recurrence

  5 years

• multiple primary carcinomas

  5 years

• distant metastasis

  5 years

• postoperative change from Baseline in quality of life score (UW-QOL questionnaire)

  1-5 years

Interventions

resection PROCEDURE

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

adjuvant radiotherapy RADIATION

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

neoadjuvant chemotherapy or adjuvant chemotherapy DRUG

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• patients decline to participate the study
• refusal or inability to receive definitive treatment for the disease
• recurrent tumors

Sponsors & Collaborators

• Beijing Stomatological Hospital, Capital Medical University: lead
• Peking University Hospital of Stomatology: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Beijing Friendship Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Beijing Chao Yang Hospital: collaborator

Study Sites (7)

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

Beijing, Beijing Municipality, 100038, China

Location

Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100043, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Stomatological Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

School of Stomatology, Peking University

Beijing, Beijing Municipality, 100081, China

Location

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

Zhengzhou, Henan, 450052, China

Location

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

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (3)

• 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.

  PMID: 36239788 DERIVED

• 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.

  PMID: 35883131 DERIVED

• 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.

  PMID: 30926067 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Investigators plan to retrieve the fresh and paraffin-embedded tissue specimens after primary tumors are resected from the biobank in all of the centers during the whole study phase. The total number of fresh and paraffin-embedded tissue specimens are approximately 30000. Specimen types include non-cancerous matched tissues and cancer tissues. These specimens will be used to complete the analysis of genetics and epigenetics in the further study. And samples of blood and saliva are also collected.Investigators plan to draw fresh blood and saliva sample from patients treated in the departments. Biomarkers of saliva, plasma separation and DNA samples of whole blood will be used for further translational medicine study.

MeSH Terms

Conditions

Head and Neck Neoplasms; Postoperative Complications

Interventions

Radiotherapy, Adjuvant; Neoadjuvant Therapy; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy; Drug Therapy

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 23, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)