MOSES: Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Number of Primary Cancers Identified [Within one year of surgery]
Cancer identified in tonsil and tongue base resections
Secondary Outcome Measures
- Pain after tongue base mucosectomy [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
- Swallow function after tongue base mucosectomy [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
Eligibility Criteria
Criteria
Inclusion Criteria:
• 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom |
Sponsors and Collaborators
- Royal Marsden NHS Foundation Trust
- Oracle Cancer Trust
- Institute of Cancer Research, United Kingdom
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- CCR5065