Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning

NCT04151134 | Active Not Recruiting

• 1 other identifier: CCR5065
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma of the Oropharynx

Outcome Measures

Primary Outcomes (1)

• Number of Primary Cancers Identified

  Cancer identified in tonsil and tongue base resections

  Within one year of surgery

Secondary Outcomes (2)

• Pain after tongue base mucosectomy

  week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks

• Swallow function after tongue base mucosectomy

  week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks

Interventions

Step serial sectioning histological processing DIAGNOSTIC_TEST

Step serial sectioning histological processing

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Aged 16 or over
• Both sexes
• Cervical metastatic SCC, confirmed with cytology or biopsy, undergoing TBM for identification of primary site

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: collaborator
• Oracle Cancer Trust: collaborator
• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tonsil and tongue base resection specimens,buccal swab and/or blood samples

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: November 5, 2019
• Study Start: November 1, 2019
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)