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出境医 / 临床实验 / A Registered Cohort Study on Spastic Paraplegia
A Registered Cohort Study on Spastic Paraplegia
Study Description
Brief Summary:
The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias(HSP) and related disorders in a prospective multicenter natural history study, to assess the clinical, genetic and epigenetic features of patients with Spastic Paraplegias to optimize clinicalmanagement..
| Condition or disease |
|---|
| Spastic Paraplegia |
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 20 Years |
| Official Title: | A Registered Cohort Study on Spastic Paraplegia |
| Actual Study Start Date : | July 1, 2019 |
| Estimated Primary Completion Date : | December 2039 |
| Estimated Study Completion Date : | December 2049 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Spastic Paraplegia Rating Scale (SPRS) [ Time Frame: 6 months ]Disease severity will be assessed by application of the Spastic Paraplegia Rating Scale (SPRS), a clinical rating scale measuring disease severity in Hereditary Spastic Paraplegia (Schule et al. Neurology 2006). The SPRS contains 13 items, each ranging from 0 to 4 points. The total score is calculated as the sum of all items, yielding a range for the total score between 0 and 52. Hereby, higher SPRS total scores indicate more severe disease.
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients diagnosed in hosipital and their's family
Criteria
Inclusion Criteria:
- Patients with the clinical diagnosis of spastic paraplegia
- Clinical diagnosis of patients with spastic paraplegia
- Unrelated healthy controls
Exclusion Criteria:
- Decline to participate.
- There are serious interferences with individual participation and adherence to the research protocol, including but not limited to neurological, psychological, and/or medical conditions.
Contacts and Locations
Contacts
| Contact: Yi Lin, MD,PhD | +13615039153 | wanjinchen75@fjmu.edu.cn | |
| Contact: Wan-Jin Chen, MD,PhD | +1386061359 ext +1386061359 | wanjinchen75@fjmu.edu.cn |
Locations
| China | |
| First Affiliated Hospital Fujian Medical University | Recruiting |
| Fuzhou, China | |
| Contact: Wan-Jian Chen, MD, PhD wanjinchen75@fjmu.edu.cn | |
| Principal Investigator: Wan-Jin Chen | |
| Sub-Investigator: Ning Wang | |
Sponsors and Collaborators
Wan-Jin Chen
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 1, 2019 | ||||||||
| First Posted Date | July 5, 2019 | ||||||||
| Last Update Posted Date | September 24, 2019 | ||||||||
| Actual Study Start Date | July 1, 2019 | ||||||||
| Estimated Primary Completion Date | December 2039 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Spastic Paraplegia Rating Scale (SPRS) [ Time Frame: 6 months ] Disease severity will be assessed by application of the Spastic Paraplegia Rating Scale (SPRS), a clinical rating scale measuring disease severity in Hereditary Spastic Paraplegia (Schule et al. Neurology 2006). The SPRS contains 13 items, each ranging from 0 to 4 points. The total score is calculated as the sum of all items, yielding a range for the total score between 0 and 52. Hereby, higher SPRS total scores indicate more severe disease.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | A Registered Cohort Study on Spastic Paraplegia | ||||||||
| Official Title | A Registered Cohort Study on Spastic Paraplegia | ||||||||
| Brief Summary | The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias(HSP) and related disorders in a prospective multicenter natural history study, to assess the clinical, genetic and epigenetic features of patients with Spastic Paraplegias to optimize clinicalmanagement.. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
||||||||
| Target Follow-Up Duration | 20 Years | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients diagnosed in hosipital and their's family | ||||||||
| Condition | Spastic Paraplegia | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 2049 | ||||||||
| Estimated Primary Completion Date | December 2039 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04006418 | ||||||||
| Other Study ID Numbers | MRCTA,ECFAH OF FMU[2019]194 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Wan-Jin Chen, First Affiliated Hospital of Fujian Medical University | ||||||||
| Study Sponsor | Wan-Jin Chen | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | First Affiliated Hospital of Fujian Medical University | ||||||||
| Verification Date | September 2019 | ||||||||
