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Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04151134
Acronym
MOSES
Enrollment
100
Registered
2019-11-05
Start date
2019-11-01
Completion date
2030-12-01
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of the Oropharynx

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.

Interventions

DIAGNOSTIC_TESTStep serial sectioning histological processing

Step serial sectioning histological processing

Sponsors

Royal Marsden NHS Foundation Trust
Lead SponsorOTHER
Oracle Cancer Trust
CollaboratorUNKNOWN
Institute of Cancer Research, United Kingdom
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Primary Cancers IdentifiedWithin one year of surgeryCancer identified in tonsil and tongue base resections

Secondary

MeasureTime frameDescription
Pain after tongue base mucosectomyweek 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeksNumeric Pain Scale. A person rates their pain on a scale of 0 to 10
Swallow function after tongue base mucosectomyweek 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeksPatients 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026