Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning (MOSES)

October 26, 2022 updated by: Royal Marsden NHS Foundation Trust

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Birmingham, United Kingdom
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
          • Ms Somiah Siddiq

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Primary Cancers Identified
Time Frame: Within one year of surgery
Cancer identified in tonsil and tongue base resections
Within one year of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Squamous Cell Carcinoma of the Oropharynx

Clinical Trials on Step serial sectioning histological processing

  • Foundation for Innovative New Diagnostics, Switzerland
    All India Institute of Medical Sciences, New Delhi; University of California... and other collaborators
    Active, not recruiting
    Tuberculosis
    Uganda, India, South Africa
Subscribe