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

NCT02607605 | Unknown DMC

• 1 other identifier: 201507004
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Meningeal Carcinomatosis

Keywords

lung cancer; leptomeningeal metastases; cell-free DNA

Outcome Measures

Primary Outcomes (1)

• positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid

  2 years

Secondary Outcomes (1)

• The relationship between the number of cell-free DNA and OS

  2 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University of cancer center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 25605683 RESULT

• 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.

  PMID: 24705333 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

patient's cerebrospinal fluid

MeSH Terms

Conditions

Lung Neoplasms; Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases

Study Officials

• li-kun Chen, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

li-kun chen, Doctor

CONTACT

13798019964; chenlk@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 18, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: August 1, 2020
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CN (1)