University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
NCT Number: NCT04151134
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.
This study is active but is not currently recruiting participants.
Notify Me16 year and older
All sexes
Observational
Birmingham, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Step serial sectioning histological processing
Time frame: Within one year of surgery
Cancer identified in tonsil and tongue base resections
Time frame: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
Numeric Pain Scale. A person rates their pain on a scale of 0 to 10
Time frame: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
Patients will be given the MDADI questionnaire in which they will be asked a series of questions with the following possible answers: completely agree, agree, uncertain, disagree, completely disagree
Royal Marsden NHS Foundation Trust
Other
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
Acronym: MOSES
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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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