Prospective, Observational, Real-world Oral Malignant Tumors Study

Quality of Life Clinical Trial

— POROMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02395367
• Other study ID #: BeiSH
• Status: Recruiting
• Start date: March 2015
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Beijing Stomatological Hospital
• Contact: Zhien Feng, M.D., Ph.D.
• Phone: 86-10-57099150
• Email: jyfzhen[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Neoplasms
• Postoperative Complications
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Stomatological Hospital, Capital Medical University	Beijing	Beijing
China	Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Department of Radiation Oncology, Beijing Shijitan Hospital, Capital Medical University	Beijing	Beijing
China	School of Stomatology, Peking University	Beijing	Beijing
China	Department of Oral and Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Department of Oral and Maxillofacial Surgery, First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (7)

Lead Sponsor	Collaborator
Beijing Stomatological Hospital	Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Shijitan Hospital of Capital Medical University, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Peking University Hospital of Stomatology, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	tumor recurrence	Tumor recurrence was defined as local recurrence postoperatively.	5 years
Secondary	neck recurrence	Neck recurrence was defined as regional recurrence whether was associated with local recurrence and distant metastasis or not.	5 years
Secondary	multiple primary carcinomas	The multiple primary carcinomas include second primary carcinoma and multiple synchronous primary cancers.	5 years
Secondary	distant metastasis		5 years
Secondary	postoperative change from Baseline in quality of life score (UW-QOL questionnaire)	The comparison between preoperative and postoperative quality of life score using UW-QOL questionnaire.	1-5 years
Secondary	postoperative change from Baseline in anxiety and depression (Hospital Anxiety and Depression Scale, and Distress Thermometer)	The comparison between preoperative and postoperative score of anxiety and depression using "Hospital Anxiety and Depression Scale" and "Distress Thermometer".	1-5 years
Secondary	postoperative complications	The postoperative complications were evaluated according to the Clavien-Dindo classification and the Accordion classification.	10 days; 42 days; 90 days
Secondary	preoperative comorbidity	The preoperative comorbidity was evaluated using Adult Comorbidity Evaluation -27 (ACE-27,Chinese Version).	1-5 years
Secondary	delay time of cancer diagnosis	The delay time of cancer diagnosis was calculated as the time from the chief complaint to the pathological diagnosis.	0-2 years
Secondary	Radiotherapy relative complications	The complications of postoperative radiotherapy	10 years
Secondary	The correlation among cancer family history, carcinogenesis and prognosis	The carcinogenesis and prognostic role of family history in patients with head and neck malignancies	10 years