Description

Salivary gland cancers (SGC) are a group of rare cancers (around 8 or 9 per 1m people pa or < 800 new cases pa), which present a range of histological and clinical behaviours. They are generally slow growing, and patients can be followed up for 10 years or more before one is confident of the natural history of the histological entity. There is little or no strong evidence for their management as RCTs are too difficult or impossible to conduct for those cancers. One must rely instead on “real world” data, which can be collected in a controlled and standardised fashion in a clinical registry.

The SGC registry is a multidisciplinary project led by the British Association of Oral and Maxillofacial Surgeons (BAOMS). The SGC registry was designed by a Working Group that included OMFS consultants, the BAOMS Salivary Gland SSIG Lead and Deputy Lead, a Head and Neck pathologist, an OMF pathologist, a medical oncologist and representatives from Salivary Gland Cancer UK.

The registry collects both clinical information and patient-reported outcomes at various time-points.

What will that involve?

The first step is to contact your Information Governance or Audit department at your hospital to register the audit. The protocol and data protection impact assessment (DPIA) below should be helpful with that application. 

Once you have obtained approval, contact the BAOMS project manager to obtain your unit’s unique QR code etc.

How does the project run?

Patient consent is wholly managed online. Patients will be asked to scan a QR code (done on their phones/tablets or computers either in the department or at home) to read an information leaflet and sign a consent form. They will then be directed to the first PROM questionnaire. Subsequent questionnaires will be automatically managed by the online system. 

Important documents:

• DPIA zip file
• Clinical Report Form

Description

Numerous benign lesions, cysts or solid tumours may present in the jaws. Little is known or understood about this rare type of tumours. They may be of either odontogenic (tooth-forming, in the dental alveolus) or non-odontogenic (mainly bone) origins in the mandible (ICD10: D16.4) and maxilla (ICD10: D16.5). From a diagnosis perspective, these lesions may have similar imaging features and their location, margins, internal contents, and effects on adjacent structures are important features to diagnose them. These rare benign lesions and tumours of the jaws (RLJ) can vary in behaviour, and despite being benign, some can grow rapidly and result in destruction of surrounding structures. Many require often-morbid treatment to prevent their recurrence. In recent years / decades, less invasive and adjunctive treatments have become available to lessen the morbidity associated with surgical treatment. As the molecular and genomic pathogenesis of these lesions is better understood, more directed treatments may lessen the burden for patients.

QOMS is already running an audit / service evaluation for oncology & reconstruction, this means that patients affected by these conditions and undergoing reconstruction to treat their defect may already be included in QOMS. However, that registry does not collect specific data on RLJ or data about patients that do not have reconstruction.

What will that involve?

The first step is to contact your Information Governance or Audit department at your hospital to register the audit. The protocol and data protection impact assessment (DPIA) below should be helpful with that application. 

How does the project run?

Patient consent is wholly managed online. Patients will be asked to scan a QR code (done on their phones/tablets or computers either in the department or at home) to read an information leaflet and sign a consent form.

Important documents/links

• RLJ Starter Pack zip file
• Clinical report form 
• QOMS FlexFacs webinar: Management of rare benign lesions of the jaw and the launch of a new national registry by Professor Mark McGurk, Mr Vinod Patel, Mr Michael Ho, Professor Keith Hunter and Dr Fabien Puglia

Description

Mandibular defects represent a major challenge for modern maxillofacial surgery. Partial or total losses of the lower jaw inevitably result in functional disorders (chewing, swallowing, breathing and speaking) and morphological issues (cosmetic deficiencies, facial disproportion), both contributing to a patient’s social maladaptation, permanent disability, mental disorders and decreased quality of life. Mandibular defects may have different origins (e.g. malignant and benign tumours, iatrogenic, trauma, congenital…) and may affect adjacent structure like the tongue, the buccal mucosa or the skin.

Procedures to treat these defects and restore function and cosmesis include free bone grafting procedures, free tissue transfer, and endoprostheses (alone or in combination). The rapidly expanding range of options available to surgeons from device companies as well as the increasing costs per patient creates a need for a registry of device use and for the post-marketing surveillance of outcomes to identify patient safety issues at the earliest possible stage.

What will that involve?

This registry is an add-on to the QOMS Oncology & Reconstruction registry.

The first step is to contact your Information Governance or Audit department at your hospital. If you are already taking part to the QOMS Oncology & Reconstruction registry, you simply need to inform them of the registry extension to collect this new data. Once obtained you, data collection can start.

Important documents

• Protocol 
• Clinical report form 

The treatment of oral cancers may result in the removal of teeth or bone-bearing teeth. This is likely to lead to significant functional impairment (chewing, breathing, speech…), which need to be corrected. Specialist Restorative Dentistry provide services for patients with complex oral and dental problems. It involves replacing missing teeth, repairing damaged teeth and extends to rehabilitation of the whole mouth. The levels of complexity of the service provided are determined by a combination of procedural difficulty, patient- and clinical-related factors and integrated treatment needs.

The Restorative dentistry / Oral rehabilitation for head and neck / oral cancer patients (RD) registry is collaboration between oral and maxillofacial surgeons and consultants restorative dentists.

What will that involve?

This registry is an add-on to the QOMS Oncology & Reconstruction registry and collects both clinical information and patient-reported outcomes.

The first step is to contact your Information Governance or Audit department at your hospital.

• Collection of clinical information: if you are already taking part to the QOMS Oncology & Reconstruction registry, you simply need to inform them of the registry extension to collect this new data. Once obtained you, data collection can start.
• Collection of patient-reported information: this part of the work needs to be registered with your Information Governance or Audit department. To support your application, you can use the information available in the protocol and DPIA below.

How does the project run?

• Patient consent is wholly managed online. Patients will be asked to scan a QR code (done on their phones/tablets or computers either in the department or at home) to read an information leaflet and sign a consent form. They will then be directed to the first PROM questionnaire. Subsequent questionnaires will be automatically managed by the online system.

Important documents

• OR Starter Pack zip file
• Clinical report form