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

Lung Neoplasms Clinical Trial

— ctDNA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02607605
• Other study ID #: 201507004
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Lung Neoplasms
• Meningeal Carcinomatosis

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