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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02607605
Other study ID # 201507004
Secondary ID
Status Recruiting
Phase N/A
First received November 16, 2015
Last updated October 25, 2017
Start date August 2015
Est. completion date August 2020

Study information

Verified date October 2017
Source Sun Yat-sen University
Contact li-kun chen, Doctor
Phone 13798019964
Email chenlk@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date August 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Patient who was confirmed primary lung cancer by pathologic histology or cytology

2. Adult patients (=18 years and =75 years). ECOG Performance Status 0 or 1.Life expectancy of at least 12 weeks.

3. Clinical symptoms and imaging tests are highly suspicious of advanced lung cancer with leptomeningeal metastases

4. Without contraindications to lumbar puncture

Exclusion Criteria:

1. Patients who have primary benign or malignant brain tumor and metastatic malignant brain tumor

2. Patients who have contraindications to lumbar puncture

3. 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Sun Yat-sen University of cancer center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Newman AM, Bratman SV, To J, Wynne JF, Eclov NC, Modlin LA, Liu CL, Neal JW, Wakelee HA, Merritt RE, Shrager JB, Loo BW Jr, Alizadeh AA, Diehn M. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med. 2014 Ma — View Citation

Pan W, Gu W, Nagpal S, Gephart MH, Quake SR. Brain tumor mutations detected in cerebral spinal fluid. Clin Chem. 2015 Mar;61(3):514-22. doi: 10.1373/clinchem.2014.235457. Epub 2015 Jan 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid 2 years
Secondary The relationship between the number of cell-free DNA and OS 2 years
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