Retrospective Study on Leptomeningeal Metastasis of Solid Tumors

NCT06705049 | Enrolling By Invitation DMC

• 1 other identifier: KY2024687
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leptomeningeal Metastasis

Outcome Measures

Primary Outcomes (1)

• Overall Survival

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

  2024/01/01-2024/08/31

Interventions

MRI RADIATION

On MRI, some lesions present as linear enhancement, while others exhibit nodular enhancement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with leptomeningeal metastases

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Tao Xie

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 26, 2024
• Study Start: October 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)