An observational study in Leptomeningeal Metastasis, sponsored by Shanghai Zhongshan Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by Shanghai Zhongshan Hospital · Observational
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.
Experimental Procedure：
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.
Imaging Data
Imaging data, including preoperative, postoperative, and follow-up imaging studies, were retrieved and copied from the hospital's Picture Archiving and Communication System (PACS).
Statistical Analysis
All collected data were subjected to statistical analysis to evaluate trends, correlations, and factors influencing patient outcomes. Specific statistical methods include:
Descriptive statistics to summarize demographic and clinical characteristics Inferential statistics to analyze potential associations between variables and survival outcomes Multivariate regression models to identify prognostic factors
By adhering to these methods, the study aims to provide insights into the clinical characteristics and survival outcomes of LM patients while maintaining ethical and methodological rigor.
3,514 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.
This study's planned enrollment of 107 is below the median of 121 across 593 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with leptomeningeal metastases
Exclusion Criteria:
On MRI, some lesions present as linear enhancement, while others exhibit nodular enhancement
Overall Survival
The survival period from the time of diagnosis of leptomeningeal metastases (LM) to the time of death.
Time frame: 2024/01/01-2024/08/31
Plan to share: No — no relative sharing plan
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Shanghai Zhongshan Hospital