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临床试验/NCT06705049
NCT06705049Enrolling By Invitation不适用

Retrospective Study on Leptomeningeal Metastasis of Solid Tumors

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
107
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

The goal of this observational study is to investigate the clinical characteristics, treatment outcomes, and prognostic factors of leptomeningeal metastasis (LM), a serious complication of advanced cancer. LM occurs when tumor cells spread to the leptomeninges and subarachnoid space, leading to neurological symptoms and poor prognosis. This study aims to answer:

What are the common clinical features of LM? How do different treatments affect survival and quality of life? What factors influence patient outcomes?

Background With advancements in cancer treatment, patient survival has improved significantly, but late-stage complications like LM are becoming more common. LM is seen in about 5% of patients with metastatic cancers such as lung cancer, breast cancer, and melanoma. Symptoms can range from mild headaches and nausea to severe neurological issues, including vision loss, hearing impairment, or limb weakness, making LM challenging to diagnose and treat.

Diagnosis often involves MRI with gadolinium enhancement and cerebrospinal fluid (CSF) analysis. Treatment options include intrathecal chemotherapy, targeted therapy, radiotherapy, and supportive care. However, LM remains a condition with poor prognosis, and there are no standardized treatment guidelines.

Study Design This study will retrospectively review LM cases treated at our hospital. Data will include: Patient demographics (age, gender, cancer type)Symptoms and clinical findings Treatment types (e.g., chemotherapy, targeted therapy, radiotherapy) Survival outcomes and factors influencing prognosis

Hypothesis The findings from this study aim to provide better insight into LM's clinical characteristics and treatment outcomes. This will help guide more effective, individualized treatment approaches and improve quality of life for patients with LM.

详细描述

Experimental Procedure:

  1. Case Collection This study collected all cases of leptomeningeal metastasis (LM) diagnosed through cerebrospinal fluid cytology at our center between January 2014 and August 2024. The collected data includes:Demographic information: Age, gender Clinical presentation: Chief complaints, current medical history, past medical history Pathological data: Pathology reports Laboratory findings: Blood lipids, renal function, platelet counts Physical characteristics: Body mass index (BMI), smoking history Surgical records: Detailed records of any surgeries Imaging data: Preoperative, postoperative, and follow-up imaging studies Survival data: Patient survival status and outcomes
  2. Data Collection Methods Follow-up and Survival Information

Survival data and follow-up information were collected via telephone interviews with patients or their families.

Medical History and General Information

Current medical history, past medical history, and other general information were extracted from hospital inpatient medical records.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a previously or recently diagnosed solid tumor in other parts of the body.
  • Detection of metastatic tumor cells in cerebrospinal fluid (CSF) cytology examination.
  • The patient has signed an informed consent form for the donation of biological samples and health-related information.
  • Age between 18 and 80 years.
  • The participant is willing to take part in this study.

排除标准

  • Presence of a clearly defined single intracranial lesion with a mass effect.
  • Pregnancy or breastfeeding.
  • Any other conditions deemed unsuitable for participation in this clinical trial, as evaluated by the physician.

结局指标

主要结局

Overall Survival

时间窗: 2024/01/01-2024/08/31

The survival period from the time of diagnosis of leptomeningeal metastases (LM) to the time of death.

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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