ctDNA: A Prospective, Observational Trial on the Diagnostic and Prognostic of LM

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02607605

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to compare the positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid in Advanced lung cancer with leptomeningeal metastases.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Meningeal Carcinomatosis

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

A Prospective, Observational Trial on the Diagnostic and Prognostic Value of Cell-free DNA in Advanced Lung Cancer With Leptomeningeal Metastases

Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Aug 1, 2020

Outcome Measures

Primary Outcome Measures

positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid [2 years]

Secondary Outcome Measures

The relationship between the number of cell-free DNA and OS [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient who was confirmed primary lung cancer by pathologic histology or cytology
Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1.Life expectancy of at least 12 weeks.
Clinical symptoms and imaging tests are highly suspicious of advanced lung cancer with leptomeningeal metastases
Without contraindications to lumbar puncture

Exclusion Criteria:

Patients who have primary benign or malignant brain tumor and metastatic malignant brain tumor
Patients who have contraindications to lumbar puncture
Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease