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NCT Number: NCT04151134

Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Step serial sectioning histological processing

Diagnostic Test

Step serial sectioning histological processing

Primary outcomes

  1. Number of Primary Cancers Identified

    Time frame: Within one year of surgery

    Cancer identified in tonsil and tongue base resections

Secondary outcomes

  1. Pain after tongue base mucosectomy

    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

  2. Swallow function after tongue base mucosectomy

    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

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Collaborators

  • Institute of Cancer Research, United Kingdom
  • Oracle Cancer Trust

Registry information

Official study 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

Acronym: MOSES

Important dates

Study start
2019
Primary completion
2029
Study completion
2030
First posted
Nov 5, 2019
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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