Methylated DNA Detect in Paraneoplastic Syndrome of Nervous System

July 1, 2020 updated by: Peking University Third Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We recruited consecutive patients with paraneoplastic syndrome.

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Lung cancer with positive methylated DNA
Blood DNA methylation abnormalities are found in lung cancer.
Other: Lung cancer
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.
Other: Positive methylated 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.
Lung cancer with negative methylated DNA
Blood DNA methylation abnormalities are not found in lung cancer.
Other: Lung cancer
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 positive methylated DNA
Blood DNA methylation abnormalities are found in suspected lung cancer.
Other: Positive methylated 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.
Other: Suspected lung cancer
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
Blood DNA methylation abnormalities are not found in suspected lung cancer.
Other: Suspected lung cancer
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year after recruitment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of mRS score
Time Frame: 1 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 after recruitment
Survival time
Time Frame: 1 years after recruitment
The time interval from disease diagnosis to death
1 years after recruitment
1-year mortality rate
Time Frame: 1 year after recruitment
The rate of death among all the inclusion patients after 1 year
1 year after recruitment
Incidence of lung cancer
Time Frame: 1 year after recruitment
The rate of lung cancer occurence among all the inclusion patients
1 year after recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PUTH2017351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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