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Methylated DNA Detect in Paraneoplastic Syndrome of Nervous System

Completed
Conditions
Paraneoplastic Neurological Syndrome
Interventions
Other: Lung cancer
Other: Suspected lung cancer
Other: Positive methylated DNA
Registration Number
NCT04454853
Lead Sponsor
Peking University Third Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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.
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Exclusion Criteria
  • Lacunar infarction
  • Aortic atherosclerotic cerebral infarction
  • Clear cardiogenic cerebral infarction
  • Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Lung cancer with negative methylated DNALung cancerBlood DNA methylation abnormalities are not found in lung cancer.
Lung cancer with positive methylated DNAPositive methylated DNABlood DNA methylation abnormalities are found in lung cancer.
Lung cancer with positive methylated DNALung cancerBlood DNA methylation abnormalities are found in lung cancer.
Suspected lung cancer with negative methylated DNASuspected lung cancerBlood DNA methylation abnormalities are not found in suspected lung cancer.
Suspected lung cancer with positive methylated DNASuspected lung cancerBlood DNA methylation abnormalities are found in suspected lung cancer.
Suspected lung cancer with positive methylated DNAPositive methylated DNABlood DNA methylation abnormalities are found in suspected lung cancer.
Primary Outcome Measures
NameTimeMethod
Level of cf-DNA1 year after recruitment

Tumor-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.

Secondary Outcome Measures
NameTimeMethod
Incidence of lung cancer1 year after recruitment

The rate of lung cancer occurence among all the inclusion patients

Survival time1 years after recruitment

The time interval from disease diagnosis to death

Changes of mRS score1 year after recruitment

Documentation in the medical record of a Modified Rankin Score (mRS). The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months (90 days) following hospital discharge.

1-year mortality rate1 year after recruitment

The rate of death among all the inclusion patients after 1 year

Trial Locations

Locations (1)

Peking University Third Hospital

🇨🇳

Beijing, China

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