Squamous Cell Carcinoma of the OropharynxMOSESNCT04151134
Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning
An observational study of Squamous Cell Carcinoma of the Oropharynx, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oropharynx
- What is being tested?
- Step serial sectioning histological processing
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2019to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cervical metastatic SCC, confirmed with cytology or biopsy, undergoing TBM for identification of primary site
Who may be able to join
- Aged 16 or over
- Both sexes
- Cervical metastatic SCC, confirmed with cytology or biopsy, undergoing TBM for identification of primary site
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham
About this study
Official 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
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.
- Being tested
- Step serial sectioning histological processing
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step serial sectioning histological processingDiagnostic test
Step serial sectioning histological processing
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Primary Cancers Identified
Cancer identified in tonsil and tongue base resections
Measured: Within one year of surgery
Secondary outcomes (2)
Pain after tongue base mucosectomy
Numeric Pain Scale. A person rates their pain on a scale of 0 to 10
Measured: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
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
Measured: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the OropharynxStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oracle Cancer Trust, Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151134
- Sponsor's protocol ID
- CCR5065
- Acronym
- MOSES
- Status last verified
- Feb 2026
- First submitted
- 10 Oct 2019
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04151134
- Acronym / sponsor ID
- MOSES / CCR5065
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Oracle Cancer Trust, Institute of Cancer Research, United Kingdom
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cervical metastatic SCC, confirmed with cytology or biopsy, undergoing TBM for identification of primary site
Key inclusion criteria (3 listed)
- Aged 16 or over
- Both sexes
- Cervical metastatic SCC, confirmed with cytology or biopsy, undergoing TBM for identification of primary site
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step serial sectioning histological processingStep serial sectioning histological processing | Diagnostic test | – |
Primary outcome
Number of Primary Cancers Identified
Time frame: Within one year of surgery
Cancer identified in tonsil and tongue base resections
2 secondary outcomes
Pain after tongue base mucosectomy
Time frame: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
Swallow function after tongue base mucosectomy
Time frame: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of the Oropharynx, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Primary Cancers Identified (time frame: Within one year of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.