Evaluating a new surgical technique for identifying cancer origins in the oropharynx
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
This study is testing a new surgery to see if removing tissue from the back of the tongue can help find the original source of cancer in patients with oropharyngeal squamous cell carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Birmingham) |
| Trial ID | NCT04151134 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with squamous cell carcinoma (SCC) of the oropharynx, particularly those with cervical metastases and unknown primary sites. It employs a surgical technique called tongue base mucosectomy (TBM) to remove tissue from the back of the tongue for analysis. The goal is to determine if the primary cancer is contained within this tissue, which could aid in better diagnosis and treatment planning. The study will also utilize step serial sectioning histological processing to examine the removed tissue.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16 or older with confirmed cervical metastatic SCC who are undergoing TBM.
Not a fit: Patients who have already identified their primary cancer site or have a history of previous head and neck cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved identification of cancer origins, allowing for more targeted and effective treatment options for patients.
How similar studies have performed: While this specific approach is relatively novel, similar studies have shown promise in identifying unknown primary cancers in other regions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom (Recruiting)
Study contacts
- Study coordinator: John C Hardman, MBChB
- Email: johncharles.hardman@nhs.net
- Phone: +442073528171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.