Omics-based Precision Medicine of Epilepsy

NCT03358459 | Unknown

• 1 other identifier: 2016YFC0904400(1)
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is a major disease of the nervous system (WHO, 2015), as well as the second most common neural disease. It has been recorded that there have been 65 million epilepsy patients all over the world, more than 10 million in China, resulted in high morbidity, high mortality, heavy social and social psychological burden. Due to complex etiology, which genetic playing a large part for 70%-80%, easy to recurrent, as well as various seizure types, a great heterogeneity in clinical manifestation, epilepsy is difficult to treat in general, at least 33% patients. At present, It's still a big challenge in early warning, choice of treatment, efficacy and severe adverse reaction rate, prognosis assessment. Lack of precise diagnosis based genetic and molecular bio-markers for treatment are the main key points. Recently, clinical phenotype classifications of epilepsy have been refined, the exist researches had made a progress in gene mutation mechanism and targeted therapy, which pushed epilepsy being another disease could be precise treated after tumor. It's sure to provide a breakthrough for another neural diseases if epilepsy precise treatment project are successful.

Conditions

Epilepsy Idiopathic; Clinical Disease and/or Syndrome; Gene Mutation

Keywords

phenotype; genotype

Outcome Measures

Primary Outcomes (1)

• The important bio-markers for the efficient therapy and prognosis

  the gene mutation or chromosome missing or duplication

  2017.02-2018.07

Study Arms (1)

EP

For diagnosis non-acquired epilepsy;

Other: non

Interventions

non OTHER

non

EP

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

15000 children and adolescent patients; 5000 adult patients

You may qualify if:

• non-acquired epilepsy; family involved(children, father and mother); Han nationality; Consent and will to follow up

You may not qualify if:

• Acquired epilepsy; Very low birth weight infant

Sponsors & Collaborators

• Fudan University: lead
• Huashan Hospital: collaborator
• Peking University First Hospital: collaborator
• Peking University People's Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Children's Hospital of Chongqing Medical University: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Capital Medical University: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Related Publications (1)

• EpiPM Consortium. A roadmap for precision medicine in the epilepsies. Lancet Neurol. 2015 Dec;14(12):1219-28. doi: 10.1016/S1474-4422(15)00199-4. Epub 2015 Sep 20.

  PMID: 26416172 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum 2 ml ; whole blood 3 ml;

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wang yi, Dr

  leader

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang yi, Dr

CONTACT

+8613564766228; yiwang@shmu.edu.cn

Long Shasha, Dr

CONTACT

+8615721029985; longshasha9985@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice prsident

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: November 30, 2017
• Study Start: November 25, 2017
• Primary Completion: November 26, 2017
• Study Completion: July 1, 2018
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

CN (1)