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NCT Number: NCT02395367

Prospective, Observational, Real-world Oral Malignant Tumors Study

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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Life

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. tumor recurrence

    Time frame: 5 years

    Tumor recurrence was defined as local recurrence postoperatively.

  2. neck recurrence

    Time frame: 5 years

    Neck recurrence was defined as regional recurrence whether was associated with local recurrence and distant metastasis or not.

  3. multiple primary carcinomas

    Time frame: 5 years

    The multiple primary carcinomas include second primary carcinoma and multiple synchronous primary cancers.

  4. distant metastasis

    Time frame: 5 years

  5. 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.

  6. 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".

  7. 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.

  8. preoperative comorbidity

    Time frame: 1-5 years

    The preoperative comorbidity was evaluated using Adult Comorbidity Evaluation -27 (ACE-27,Chinese Version).

  9. 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.

  10. Radiotherapy relative complications

    Time frame: 10 years

    The complications of postoperative radiotherapy

  11. 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

Sponsors and collaborators

Lead sponsor

Beijing Stomatological Hospital, Capital Medical University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: POROMS

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2015
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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