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临床试验/NCT05454163
NCT05454163撤回不适用

Evaluation of Chronic Rhinosinusitis in Children Managed for Cervicofacial Mesenchymal Malignancy

University Hospital, Lille0 个研究点目标入组 55 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
55
主要终点
Impact of CRS in pediatric patients by Sino-Nasal Outcome Test-22 (SNOT 22)

研究概览

简要总结

Chronic rhinosinusitis (CRS) is a frequent complication of facial cancer treatment, mainly related to radiotherapy. However, while radiological involvement is frequent, clinical expression seems less important.

Few studies have investigated the incidence of this condition in the pediatric population while its evolution seems to be very chronic even if a partial improvement may occur with time.

Our objective is therefore to study the impact of CSR in children treated for cancer of the cervicofacial region, to evaluate its incidence and medium-term evolution in order to determine whether it is necessary to set up a specific follow-up in these patients.

The clinical impact of CSR is assessed by a specific SNOT 22 questionnaire in children treated for a head-neck mesenchymal malignancy in comparison with a control population consisting of children treated for a mesenchymal malignancy of non-head-neck location.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Study population: all patients under 18 years of age managed for a head neck mesenchymal cancer between January 1, 2018 and December 31, 2024
  • Control population: all patient under 1 years of age managed for non -head neck mesenchymal cancer between January 1, 2018 and December 31, 2024

排除标准

  • Patients with hematological tumors;
  • Patients with mucociliary pathologies or proven allergic rhinitis before the diagnosis of cancer
  • Patients who have required surgical treatment that has removed more than half of the sinus cavities
  • Tumor recurrence at the time of inclusion
  • Sinus surgery between the last radiological check-up and inclusion
  • Administrative reasons: inability to receive informed information.

结局指标

主要结局

Impact of CRS in pediatric patients by Sino-Nasal Outcome Test-22 (SNOT 22)

时间窗: >1 year to <4 years after the end of oncologic treatment

次要结局

  • Correlation between SNOT 22 and clinical assessment by PADORES score(>1 year to <4 years after the end of oncologic treatment)
  • Incidence of CRS in pediatric patients after head neck mesenchymal cancer management(1 year after the end of the oncologic treatment)
  • Correlation between SNOT 22 and radiological assessment by Lund-Mackay score(>1 year to <4 years after the end of oncologic treatment)
  • Correlation between SNOT 22 and clinical assessment by lund-kennedy score(>1 year to <4 years after the end of oncologic treatment)
  • Radiological evolution of CRS by Lund-Mackay score(>1 year to <4 years after the end of oncologic treatment)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

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