Trial record 3 of 10 for:    DIAN

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2015 by Beijing Stomatology Hospital
Sponsor:
Collaborator:
Stomatology Hospital of Peking University
Information provided by (Responsible Party):
Beijing Stomatology Hospital
ClinicalTrials.gov Identifier:
NCT02395367
First received: March 16, 2015
Last updated: March 21, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Head and Neck Neoplasms
Quality of Life
Postoperative Complications
Procedure: resection
Radiation: adjuvant radiotherapy
Drug: neoadjuvant chemotherapy or adjuvant chemotherapy

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective, Observational, Real-world Study Based on the Register System of Oral and Maxillofacial Malignant Tumors.

Resource links provided by NLM:


Further study details as provided by Beijing Stomatology Hospital:

Primary Outcome Measures:
  • disease-specific survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tumor recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • neck recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • multiple primary carcinomas [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • distant metastasis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • postoperative change from Baseline in quality of life score (UW-QOL questionnaire) [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]
  • postoperative change from Baseline in anxiety and depression (Hospital Anxiety and Depression Scale, and Distress Thermometer) [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]
  • postoperative complications [ Time Frame: 10 days; 42 days; 90 days ] [ Designated as safety issue: No ]
  • preoperative comorbidity [ Time Frame: 1-5 years ] [ Designated as safety issue: No ]
  • delay time of cancer diagnosis [ Time Frame: 0-2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 2015
Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: resection
    This is an observational study. And we are interested in observing the outcome of different treatment methods.
    Radiation: adjuvant radiotherapy
    This is an observational study. And we are interested in observing the outcome of different treatment methods.
    Drug: neoadjuvant chemotherapy or adjuvant chemotherapy
    This is an observational study. And we are interested in observing the outcome of different treatment methods.
Detailed Description:

A register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in north 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.

  Eligibility

Genders Eligible for Study:   Both
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 and stomatological hospital of Peking University.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02395367

Contacts
Contact: Zhien Feng, M.D., Ph.D. 86-10-57099150 jyfzhen@126.com
Contact: Dian Can Wang, M.D. 86-10-62179977 bjwdc@sina.com

Sponsors and Collaborators
Beijing Stomatology Hospital
Stomatology Hospital of Peking University
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.
  More Information

No publications provided

Responsible Party: Beijing Stomatology Hospital
ClinicalTrials.gov Identifier: NCT02395367     History of Changes
Other Study ID Numbers: BeiSH
Study First Received: March 16, 2015
Last Updated: March 21, 2015
Health Authority: China: Institutional Review Board of the Beijing Stomatological Hospital of Capital Medical University

Keywords provided by Beijing Stomatology Hospital:
Prognosis
Risk Factors

Additional relevant MeSH terms:
Head and Neck Neoplasms
Postoperative Complications
Neoplasms
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on March 26, 2015