Paraneoplastic Neurological SyndromeNCT04454853
Methylated DNA Detect in Paraneoplastic Syndrome of Nervous System
An observational study of Paraneoplastic Neurological Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Paraneoplastic Neurological Syndrome
- What is being tested?
- Lung cancer, Suspected lung cancer and Positive methylated DNA
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We recruited consecutive patients with paraneoplastic syndrome.
Who may be able to join
- 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.
Who cannot join
- Lacunar infarction
- Aortic atherosclerotic cerebral infarction
- Clear cardiogenic cerebral infarction
- Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Paraneoplastic Neurological Syndrome
- Being tested
- Lung cancer, Suspected lung cancer, Positive methylated DNA
- Keywords
- Paraneoplastic neurological syndrome; Cell-free DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung cancerOther
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 cancerOther
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.
Positive methylated DNAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer with positive methylated DNA | Blood DNA methylation abnormalities are found in lung cancer. Receives: Other: Lung cancer; Other: Positive methylated DNA | |
| Lung cancer with negative methylated DNA | Blood DNA methylation abnormalities are not found in lung cancer. Receives: Other: Lung cancer | |
| Suspected lung cancer with positive methylated DNA | Blood DNA methylation abnormalities are found in suspected lung cancer. Receives: 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. Receives: Other: Suspected lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after recruitment
Secondary outcomes (4)
Changes of mRS score
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.
Measured: 1 year after recruitment
Survival time
The time interval from disease diagnosis to death
Measured: 1 years after recruitment
1-year mortality rate
The rate of death among all the inclusion patients after 1 year
Measured: 1 year after recruitment
Incidence of lung cancer
The rate of lung cancer occurence among all the inclusion patients
Measured: 1 year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Dec 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraneoplastic Neurological SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongsheng Fan, MD.PHD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454853
- Sponsor's protocol ID
- PUTH2017351
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04454853
- Acronym / sponsor ID
- PUTH2017351
- Conditions
- Paraneoplastic Neurological Syndrome
- Keywords
- Paraneoplastic neurological syndrome; Cell-free DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lung cancer with positive methylated DNA | – | Other: Lung cancer, Other: Positive methylated DNABlood DNA methylation abnormalities are found in lung cancer. |
| Lung cancer with negative methylated DNA | – | Other: Lung cancerBlood DNA methylation abnormalities are not found in lung cancer. |
| Suspected lung cancer with positive methylated DNA | – | Other: Suspected lung cancer, Other: Positive methylated DNABlood DNA methylation abnormalities are found in suspected lung cancer. |
| Suspected lung cancer with negative methylated DNA | – | Other: Suspected lung cancerBlood DNA methylation abnormalities are not found in suspected lung cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We recruited consecutive patients with paraneoplastic syndrome.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Lacunar infarction
- Aortic atherosclerotic cerebral infarction
- Clear cardiogenic cerebral infarction
- Other related system diseases (arteritis, vascular dissection, migraine and vasospasm, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung cancerParaneoplastic 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. | Other | Lung cancer with negative methylated DNA, Lung cancer with positive methylated DNA |
| Suspected lung cancerParaneoplastic 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. | Other | Suspected lung cancer with negative methylated DNA, Suspected lung cancer with positive methylated DNA |
| Positive methylated DNATumor-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. | Other | Lung cancer with positive methylated DNA, Suspected lung cancer with positive methylated DNA |
Primary outcome
Level of cf-DNA
Time frame: 1 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.
4 secondary outcomes
Changes of mRS score
Time frame: 1 year after recruitment
Survival time
Time frame: 1 years after recruitment
1-year mortality rate
Time frame: 1 year after recruitment
Incidence of lung cancer
Time frame: 1 year after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongsheng Fan, MD.PHD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraneoplastic Neurological Syndrome, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of cf-DNA (time frame: 1 year after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.