跳至主要内容
临床试验/NCT07835412
NCT07835412招募中不适用

Role of Health Screening in Patients Undergoing Surgery for Pituitary Neuroendocrine Tumors: A Multicenter Cohort Study From the National Brain Tumor Registry of China (NBTRC)

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2026年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Preoperative maximum tumor diameter

研究概览

简要总结

This multicenter cohort study is based on the National Brain Tumor Registry of China (NBTRC). It will compare patients who underwent surgery for Pituitary Neuroendocrine Tumors (PitNETs) detected through health screening versus those diagnosed via outpatient consultations. The study will evaluate differences between the two groups in surgical metrics, patient-centered outcomes, and healthcare utilization.

详细描述

This multicenter cohort study is based on the National Brain Tumor Registry of China (NBTRC), a nationwide brain tumor registry established by the China National Clinical Research Center for Neurological Diseases.

Patients will be categorized according to their initial consultation department. The screening group will include patients whose tumors were incidentally detected during health screening. The clinical group will include patients diagnosed through outpatient consultations, which will be further subdivided into neurosurgery, ear-nose-throat/ophthalmology, other surgical specialties, and internal medicine. Group assignment will be determined by reviewing each patient's chief complaint, present illness, and past medical history.

The primary outcomes include surgery-related measures (preoperative maximum tumor diameter and extent of resection, defined as gross total resection) and patient-centered outcomes (preoperative symptom phenotype, time from symptom onset to surgery, and postoperative hormonal remission status before discharge). Secondary outcomes reflect socioeconomic burden, including operation duration, length of stay, and total hospitalization costs.

Subgroup analyses will be performed according to functional hormone subtypes. In addition to the two-group comparison between screening and clinical groups, multi-group comparisons will be conducted across different initial consultation departments, with the screening group serving as the reference. Multivariable regression models will be used to adjust for potential confounders, including age, sex, hormone type, insurance status, and hospital-level clustering.

研究设计

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

入排标准

年龄范围
1 Year 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with PitNETs who underwent surgical resection at Beijing Tiantan Hospital from September 1, 2011, to November 30, 2019, together with those recorded in the NBTRC who underwent surgery from December 1, 2019, to December 31, 2021.

排除标准

  • The department (health screening or outpatient clinics) where the definitive diagnosis confirmed was missing or unclear
  • PitNETs was recurrent or synchronous brain tumors of any histology existed
  • Admission was via the emergency department
  • Maximum tumor diameter on preoperative MRI were unavailable
  • Patients who explicitly declined to participate in this study

研究组 & 干预措施

Clinical group

Tumors were diagnosed at outpatient clinics. For patients in the clinical group, the Initial Consultation Departments will included Neurosurgery, Ear, nose and throat/Ophthalmology, Other surgical specialties, and Internal Medicine.

Screening group

Tumors were detected by health screening.

结局指标

主要结局

Preoperative maximum tumor diameter

时间窗: Within 3 months before surgery

Maximum tumor diameter in millimeters, measured on preoperative Magnetic Resonance Imaging (MRI), defined as the largest dimension of the tumor.

Extent of resection

时间窗: Within 72 hours after surgery

Gross total resection (GTR) versus non-GTR, assessed by intraoperative findings combined with MRI performed within 72 hours after surgery.

Preoperative symptom phenotype

时间窗: At hospital admission

Presence or absence of preoperative symptoms (including visual decline, headache, hyperpituitarism, hypopituitarism, diplopia, cerebrospinal fluid leak, nonspecific symptoms, and other symptoms) reported by the patient at hospital admission, reflecting symptoms experienced during the preoperative period.

Time interval from symptom onset to surgery

时间窗: At hospital admission

Time in months from the date of symptom onset to the date of surgery, calculated from patient-reported history documented in medical records.

Postoperative hormone remission status

时间窗: At hospital discharge

Biochemical remission of functioning adenomas (Prolactin \[PRL\], Growth Hormone \[GH\], Adrenocorticotropic Hormone \[ACTH\], Thyroid-Stimulating Hormone \[TSH\]) assessed before hospital discharge, based on disease-specific criteria per Endocrine Society guidelines.

次要结局

  • Length of hospital stay(At hospital discharge)
  • Operation duration(At the end of surgery)
  • Total hospitalization costs(At hospital discharge)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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