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Head and Neck NeoplasmsPOROMSNCT02395367

Prospective, Observational, Real-world Oral Malignant Tumors Study

An observational study of Head and Neck Neoplasms and Quality of Life, run by Beijing Stomatological Hospital, Capital Medical University at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
resection, adjuvant radiotherapy and neoadjuvant chemotherapy or adjuvant chemotherapy
Type of treatment
Surgery or procedure
How many people
30,000 participants
Where
7 sitesChina
Study dates
Mar 2015to Mar 2025
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

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

    Beijing, Beijing Municipality, 100038

  • Department of Otolaryngology, Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100043

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Stomatological Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • School of Stomatology, Peking University

    Beijing, Beijing Municipality, 100081

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

    Shanghai, Shanghai Municipality, 200011

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

    Zhengzhou, Henan, 450052

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
resection, adjuvant radiotherapy, neoadjuvant chemotherapy or adjuvant chemotherapy
Keywords
Prognosis, Risk Factors
Medical subject headings
Head and Neck Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • resectionProcedure or surgery

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

  • adjuvant radiotherapyRadiation

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

  • neoadjuvant chemotherapy or adjuvant chemotherapyDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (11)

  1. tumor recurrence

    Tumor recurrence was defined as local recurrence postoperatively.

    Measured: 5 years

  2. neck recurrence

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

    Measured: 5 years

  3. multiple primary carcinomas

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

    Measured: 5 years

  4. distant metastasis

    Measured: 5 years

  5. 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.

    Measured: 1-5 years

  6. 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".

    Measured: 1-5 years

  7. postoperative complications

    The postoperative complications were evaluated according to the Clavien-Dindo classification and the Accordion classification.

    Measured: 10 days; 42 days; 90 days

  8. preoperative comorbidity

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

    Measured: 1-5 years

  9. delay time of cancer diagnosis

    The delay time of cancer diagnosis was calculated as the time from the chief complaint to the pathological diagnosis.

    Measured: 0-2 years

  10. Radiotherapy relative complications

    The complications of postoperative radiotherapy

    Measured: 10 years

  11. The correlation among cancer family history, carcinogenesis and prognosis

    The carcinogenesis and prognostic role of family history in patients with head and neck malignancies

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2025
  4. Study completionMar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02395367
Sponsor's protocol ID
BeiSH
Acronym
POROMS
Status last verified
Mar 2025
First submitted
16 Mar 2015
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Zhang L, Liu C, Xu Q, Wang C, Li B, Liu H, Wang H, Feng Z. Preoperative Anxiety and Depression Symptoms Stratifying Based on Gender Differences Influence Outcome of Oral Squamous Cell Carcinoma. Head Neck. 2026 May;48(5):1165-1177. doi: 10.1002/hed.70105. Epub 2025 Nov 24.

    PubMed 41287448

  • 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.

    PubMed 36239788

  • 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.

    PubMed 35883131

  • 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.

    PubMed 30926067

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Neoplasms and Quality of Life, run by Beijing Stomatological Hospital, Capital Medical University at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease-specific survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02395367, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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