HNCIG/IFHNOS Carcinoma of Unknown Primary study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- a.In HNSCCUP non nasopharyngeal with unilateral neck disease what is the incidence of the primary tumour
研究概览
简要总结
The HNCIG/IFHNOS CUP Study focuses on improving the diagnosis and treatment of head and neck squamous cell carcinoma (HNSCC) with an unknown primary (HNSCCUP). This international collaboration aims to address diagnostic challenges, identify primary tumor sites, and assess treatment outcomes.
Key ObjectiveDefine diagnostic pathways: Explore geographical variations in diagnostic practices and procedures.Primary tumor detection: Report detection rates based on geography and p16/HPV status.Treatment outcomes: Evaluate the effectiveness of surgery, radiotherapy, and combined treatments on survival and mortality.Long-term outcomes: Provide 5-year survival and recurrence-free survival data.Work Packages:WP1 (International Survey): Identify geographical differences in diagnostic practices.WP2 (Data Collection): Retrospective study on primary site detection, treatment effects, and survival outcomes.WP3 (Delphi Consensus): Achieve international consensus on best practices for diagnosis and treatment.Participants Surgeons, clinicians, and oncologists from international centers.Data Collection Retrospective cohort with at least 50 cases per center.Ethics Waiver of consent, using de-identified historical data.Sample Size 82 patients for calculating primary site detection.Confidentiality Anonymized data stored in a secure database for future research
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 72.00 Year(s)（—）
- 性别
- All
入选标准
- •Are consecutive i.e. unselected undergoing either unilateral or bilateral tonsillectomy, tongue base mucosectomy, random biopsies, or guided biopsies for suspected HNSCCUP between 1st January 2015 and 31st December 2021 A minimum of 50 cases are required for centre participation All HNC sites will be included e.g. oral, oropharyngeal, laryngopharyngeal and nasopharyngeal Have unilateral or bilateral involved neck nodes Have a minimum of 2-year follow up or less if the patient has died.
- •Have a diagnosis of squamous cell carcinoma on FNA or core biopsy or neck node biopsy or neck dissection Must have cross sectional imaging, either CT, MRI, PET-CT or combination having a PET-CT is not mandatory.
排除标准
- •Have distant metastatic disease on presentation Are less than 18 years old.
结局指标
主要结局
a.In HNSCCUP non nasopharyngeal with unilateral neck disease what is the incidence of the primary tumour
时间窗: 1.Compare outcomes of surgery, radiotherapy, and dual modality treatments, including survival and mortality. | 2.Assess detection rates by geography, HPV p16 status, and prior tonsillectomy. | 3.Provide 5 year survival and recurrence free data.
being identified in the ipsilateral tongue base
时间窗: 1.Compare outcomes of surgery, radiotherapy, and dual modality treatments, including survival and mortality. | 2.Assess detection rates by geography, HPV p16 status, and prior tonsillectomy. | 3.Provide 5 year survival and recurrence free data.
b.To assess outcomes recurrence free survival and overall survival in a long term follow up study
时间窗: 1.Compare outcomes of surgery, radiotherapy, and dual modality treatments, including survival and mortality. | 2.Assess detection rates by geography, HPV p16 status, and prior tonsillectomy. | 3.Provide 5 year survival and recurrence free data.
c.To assess the difference in locoregional recurrence and overall survival in patients with T0N1 HNSCCUP
时间窗: 1.Compare outcomes of surgery, radiotherapy, and dual modality treatments, including survival and mortality. | 2.Assess detection rates by geography, HPV p16 status, and prior tonsillectomy. | 3.Provide 5 year survival and recurrence free data.
between those undergoing surgery or radiotherapy alone and those undergoing dual modality treatment
时间窗: 1.Compare outcomes of surgery, radiotherapy, and dual modality treatments, including survival and mortality. | 2.Assess detection rates by geography, HPV p16 status, and prior tonsillectomy. | 3.Provide 5 year survival and recurrence free data.
次要结局
- a.To determine if the rate of tongue base primary detection varies dependent on patients having had prior tonsillectomy(b) In HNSCCUP with unilateral neck disease, what is the incidence of the primary tumour in the ipsilateral)
研究者
Dr Shivakumar Thiagarajan
Tata Memorial Hospital