- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151134
Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning (MOSES)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: John C Hardman, MBChB
- Phone Number: +442073528171
- Email: johncharles.hardman@nhs.net
Study Contact Backup
- Name: Amy O'Reilly, BA Hons
- Phone Number: 1876 020 7352 8171
- Email: MOSES.Study@rmh.nhs.uk
Study Locations
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Birmingham, United Kingdom
- Recruiting
- University Hospitals Birmingham NHS Foundation Trust
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Contact:
- Ms Somiah Siddiq
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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Cancer identified in tonsil and tongue base resections
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Within one year of surgery
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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
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week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
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Swallow function after tongue base mucosectomy
Time Frame: week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
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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
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week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR5065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnRecurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Verrucous Carcinoma of the Oral Cavity | Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage I Squamous Cell Carcinoma of the Oropharynx | Stage I Verrucous... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedStage II Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage II Squamous Cell Carcinoma of the Oropharynx | Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage III Squamous Cell Carcinoma of the Oropharynx | Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity and other conditionsUnited States
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Ohio State University Comprehensive Cancer CenterCompletedTongue Cancer | Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage I Squamous Cell Carcinoma of the Oropharynx | Stage I Verrucous Carcinoma of the Oral Cavity | Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage II Squamous Cell Carcinoma of the Oropharynx | Stage... and other conditionsUnited States
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University of ChicagoNational Cancer Institute (NCI)TerminatedTongue Cancer | Stage I Squamous Cell Carcinoma of the Oropharynx | Stage II Squamous Cell Carcinoma of the Oropharynx | Stage III Squamous Cell Carcinoma of the Oropharynx | Stage IVA Squamous Cell Carcinoma of the OropharynxUnited States
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Arbeitsgemeinschaft medikamentoese TumortherapieCompletedSquamous Cell Carcinoma of the Hypopharynx Stage III | Squamous Cell Carcinoma of the Hypopharynx Stage IV | Squamous Cell Carcinoma of the Larynx Stage III | Squamous Cell Carcinoma of the Larynx Stage IV | Squamous Cell Carcinoma of the Oropharynx Stage III | Squamous Cell Carcinoma of the... and other conditionsAustria
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City of Hope Medical CenterNational Cancer Institute (NCI)TerminatedRecurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Verrucous Carcinoma of the Larynx | Recurrent Verrucous Carcinoma... and other conditionsUnited States
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National Cancer Institute (NCI)TerminatedStage III Squamous Cell Carcinoma of the Hypopharynx | Stage III Squamous Cell Carcinoma of the Larynx | Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage III Squamous Cell Carcinoma of the Oropharynx | Stage IV Squamous Cell Carcinoma of the Hypopharynx | Stage IV Squamous... and other conditionsUnited States
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyTerminatedTongue Cancer | Stage III Squamous Cell Carcinoma of the Hypopharynx | Stage III Squamous Cell Carcinoma of the Larynx | Stage III Squamous Cell Carcinoma of the Oropharynx | Stage III Verrucous Carcinoma of the Larynx | Stage IV Squamous Cell Carcinoma of the Hypopharynx | Stage IVA Squamous... and other conditionsUnited States
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedHuman Papilloma Virus Infection | Stage III Squamous Cell Carcinoma of the Hypopharynx | Stage III Squamous Cell Carcinoma of the Larynx | Stage III Squamous Cell Carcinoma of the Oropharynx | Stage III Verrucous Carcinoma of the Larynx | Stage IV Squamous Cell Carcinoma of the Hypopharynx | Stage... and other conditionsUnited States
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Mitchell MachtayNot yet recruitingSquamous Cell Carcinoma of the Oral Cavity or Oropharynx
Clinical Trials on Step serial sectioning histological processing
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Foundation for Innovative New Diagnostics, SwitzerlandAll India Institute of Medical Sciences, New Delhi; University of California... and other collaboratorsActive, not recruiting