Clinical trial NCT04454853: Methylated DNA Detect in Paraneoplastic Syndrome of Nervous System
Official title: A Research of Value of Free Methylated DNA Detect in Lung Cancer on the Diagnosis and Treatment of Paraneoplastic Syndrome of Nervous System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paraneoplastic Neurological Syndrome
Keywords: Paraneoplastic neurological syndrome; Cell-free DNA
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We recruited consecutive patients with paraneoplastic syndrome.

Brief summary: The purpose of this study is to verify whether the cell-free DNA of lung cancer in the blood can be used as a biomarker for early diagnosis and prognosis evaluation of patient with paraneoplastic syndrome of the nervous system.

Detailed description: Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible in the neuropathy. The disease is a rare clinical syndrome, and lung cancer is the most common type of tumor that causes PNS.If PNS can be diagnosed when there are no tumor symptoms, not only can the cause of PNS be identified, but early tumors can be found for treatment time, and measures can be taken in the early stages of the tumor to improve survival. Tumor free DNA (cell-free DNA, cfDNA) methylation detection is to determine the cancer condition and cancer type of the subject by detecting the methylation of free DNA released by tumor cells. In normal cells, tumor suppressor genes are expressed and proto-oncogenes are silenced; in tumor cells, tumor suppressor genes are hypermethylated and silenced, and oncogenes are hypomethylated and activated. The release of free DNA into the blood will be quickly cleared in tens of minutes to several hours, which can reflect the body's cell damage in real time, and is of great significance for monitoring the early occurrence and development of the disease. At present, the sensitivity of lung cancer cf-DNA detection technology is close to 100%, and the specificity is 94%, which is an effective detection technology for early detection of lung cancer.

Eligibility criteria: Inclusion Criteria:

* The agnogenic typical neurological syndromes (including encephalomyelitis, marginal encephalitis, subacute cerebellar degeneration, strabismus ocular clonic-myoclonus, subacute sensory neuron disease, Lambert-Eaton myasthenic syndrome, skin Myositis, etc.) patient who predisposed to a tumor.
* Pathologically confirmed as lung cancer or suggested as lung cancer patient by imaging (pulmonary CT/Positron Emission Tomography-CT), tumor biomarkers, anti-brain tissue antibodies, etc.

Exclusion Criteria:

* Lacunar infarction
* Aortic atherosclerotic cerebral infarction
* Clear cardiogenic cerebral infarction
* Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)

Primary outcomes:
measure: Level of cf-DNA
timeFrame: 1 year after recruitment
Secondary outcomes:
measure: Changes of mRS score
timeFrame: 1 year after recruitment
measure: Survival time
timeFrame: 1 years after recruitment
measure: 1-year mortality rate
timeFrame: 1 year after recruitment
measure: Incidence of lung cancer
timeFrame: 1 year after recruitment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan, MD.PHD
role: PRINCIPAL_INVESTIGATOR
References: