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Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning

NCT04151134 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-02-12

No results posted yet for this 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.

Conditions

  • Squamous Cell Carcinoma of the Oropharynx

Interventions

DIAGNOSTIC_TEST

Step serial sectioning histological processing

Step serial sectioning histological processing

Sponsors & Collaborators

  • Oracle Cancer Trust

    collaborator UNKNOWN

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2029-12-01
Completion
2030-12-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04151134 on ClinicalTrials.gov