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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Neoplasms Meningeal Carcinomatosis

Keywords

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lung cancer leptomeningeal metastases cell-free DNA

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Li-kun Chen

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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li-kun Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University of cancer center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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li-kun chen, Doctor

Role: CONTACT

Phone: 13798019964

Email: [email protected]

Facility Contacts

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li-kun chen, doctor

Role: primary

References

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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.

Reference Type RESULT

PMID: 25605683 (View on PubMed)

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 May;20(5):548-54. doi: 10.1038/nm.3519. Epub 2014 Apr 6.