CClinicalTrials.gg
Active, not recruitingNCT04151134MOSESUpdated Feb 12, 2026

Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning

An observational study in Squamous Cell Carcinoma of the Oropharynx, sponsored by Royal Marsden NHS Foundation Trust. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Royal Marsden NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Squamous Cell Carcinoma of the Oropharynx
03

In context

Squamous Cell Carcinoma of Head and Neck

1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 179 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cervical metastatic SCC, confirmed with cytology or biopsy, undergoing TBM for identification of primary site

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testStep serial sectioning histological processing

    Step serial sectioning histological processing

06

What researchers measure

Primary outcomes

  1. Number of Primary Cancers Identified

    Cancer identified in tonsil and tongue base resections

    Time frame: Within one year of surgery

Secondary outcomes

  1. Pain after tongue base mucosectomy

    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

  2. Swallow function after tongue base mucosectomy

    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

    Time frame: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks

07

Study locations

1 site
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham, United Kingdom
08

References and documents

Study documents

  • Study protocol · Mar 18, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04151134
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Oracle Cancer Trust, Institute of Cancer Research, United Kingdom
Responsible party
Sponsor
First posted
Nov 5, 2019
Start date
Nov 1, 2019
Primary completion
Dec 1, 2029 (estimated)
Completion
Dec 1, 2030 (estimated)
Last update
Feb 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion