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临床试验/NCT04151134
NCT04151134进行中(未招募)不适用

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

Royal Marsden NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Number of Primary Cancers Identified

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Number of Primary Cancers Identified

时间窗: Within one year of surgery

Cancer identified in tonsil and tongue base resections

次要结局

  • Swallow function after tongue base mucosectomy(week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks)
  • Pain after tongue base mucosectomy(week 0 , 3 weeks, 6 weeks, 12 weeks, 26 weeks and 52 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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