Clinical trial NCT04151134: Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning
Official title: Evaluation of the Role of Tongue Base MucOsectomy and Step sErial Sectioning in the Management of the Unknown Primary Squamous Cell Cancer in the Head and Neck
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Squamous Cell Carcinoma of the Oropharynx
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Oracle Cancer Trust
name: Institute of Cancer Research, United Kingdom
First posted: 2019-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cervical metastatic SCC, confirmed with cytology or biopsy, undergoing TBM for identification of primary site

Brief summary: Squamous cell carcinoma (SCC) is a cancer that originates from the cells lining the body and can spread into the lymph glands and beyond. Some patients first present with an SCC which has moved to the lymph glands of the neck. Clinical examination and imaging investigations are performed to try and identify the site where the cancer has originated. However, if no original site can be identified, then the investigators call these 'cancers of an unknown primary' (CUP) of the head and neck.

One region where these cancers could have originated from is the oropharynx. There are two areas in the oropharynx were cancers commonly arise. One area is the palatine tonsils, which can be removed for analysis with an operation called tonsillectomy. The other area is the tissue lining the back of the tongue, known as the tongue base. A relatively new surgical technique called 'tongue base mucosectomy' (TBM) allows removal of this tissue to see if the primary cancer is contained within it. This study will then use a histological method called 'step serial sectioning' (SSS) to look in more detail at the tonsils and tongue base, hoping to increase the detection rate of the primary cancer.

Centres performing TBM will be asked to participate. Patients will be asked to consent to their tissue being used for SSS after it has undergone conventional histology. Anonymised samples will be sent to a central laboratory in Newcastle for processing. Other anonymised data regarding the patients' diagnosis and care will be collated. Patients will be asked to complete questionnaires regarding pain and swallowing recovery following surgery. A smaller cohort of patients will also be interviewed as part of a qualitative research process to establish their views on CUP and the acceptability of the above treatment.


Eligibility criteria: Inclusion Criteria:

* Aged 16 or over
* Both sexes
* Cervical metastatic SCC, confirmed with cytology or biopsy, undergoing TBM for identification of primary site

Exclusion Criteria:

* Primary site identified by any means prior to being indicated for TBM
* Patients undergoing targeted biopsies or resections
* Patients known to have a history of previous H\&N cancers
* Patients known to have undergone previous radiation to the H\&N region

Primary outcomes:
measure: Number of Primary Cancers Identified
timeFrame: Within one year of surgery
Secondary outcomes:
measure: Pain after tongue base mucosectomy
timeFrame: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
measure: Swallow function after tongue base mucosectomy
timeFrame: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
Study officials:
References: