Methylated DNA Detect in Paraneoplastic Syndrome of Nervous System

NCT04454853 | Completed

• 1 other identifier: PUTH2017351
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Paraneoplastic Neurological Syndrome

Keywords

Paraneoplastic neurological syndrome; Cell-free DNA

Outcome Measures

Primary Outcomes (1)

• Level of cf-DNA

  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.

  1 year after recruitment

Secondary Outcomes (4)

• Changes of mRS score

  1 year after recruitment

• Survival time

  1 years after recruitment

• 1-year mortality rate

  1 year after recruitment

• Incidence of lung cancer

  1 year after recruitment

Study Arms (4)

Lung cancer with positive methylated DNA

Blood DNA methylation abnormalities are found in lung cancer.

Other: Lung cancer; Other: Positive methylated DNA

Lung cancer with negative methylated DNA

Blood DNA methylation abnormalities are not found in lung cancer.

Other: Lung cancer

Suspected lung cancer with positive methylated DNA

Blood DNA methylation abnormalities are found in suspected lung cancer.

Other: Suspected lung cancer; Other: Positive methylated DNA

Suspected lung cancer with negative methylated DNA

Blood DNA methylation abnormalities are not found in suspected lung cancer.

Other: Suspected lung cancer

Interventions

Lung cancer OTHER

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 at the neuropathy site.

Lung cancer with negative methylated DNA; Lung cancer with positive methylated DNA

Suspected lung cancer OTHER

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 at the neuropathy site.

Suspected lung cancer with negative methylated DNA; Suspected lung cancer with positive methylated DNA

Positive methylated DNA OTHER

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.

Lung cancer with positive methylated DNA; Suspected lung cancer with positive methylated DNA

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

We recruited consecutive patients with paraneoplastic syndrome.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

Study Officials

• Dongsheng Fan, MD.PHD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: December 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)