CadasilNCT04310098
CADASIL Registry Study
An observational study of Cadasil, run by Bin Cai at 1 site in China.
Trial summary
The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) and related disorders in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cadasil
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2020to 9 Mar 2049
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed in hosipital and their's family
Who may be able to join
- Sign informed consent.
- Age>18
- Clinical diagnosis of patients with CADASIL,and confirmed by genetic test or skin biopsy
- Asymptomatic NOTCH3 mutation carriers
- Relatives of CADASIL patients or carriers
- Unrelated healthy controls
Who cannot join
- Unable to cooperate with inspectors
- Serious systemic illness, such as heart, liver, kidney disease or major mental illness
- Contraindications for imaging examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology , First Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, 350004
Cai Bin, PhD, 13338413842 ext. 86, caibin929@163.com
About this study
Official title: Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy Registry Study
The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) and related disorders in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CADASIL , to optimize clinical management.
- Conditions
- Cadasil
- Medical subject headings
- CADASIL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CADASIL patients | Not described | |
| Asymptomatic carriers of CADASIL | Not described | |
| Relatives of CADASIL patients and carriers | Not described | |
| Unrelated healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall outcomes in CADASIL patients
record the occurrence of stroke and use modified Rankin Scale (mRS) to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Measured: From date of enrollment until the date of death from any cause, assessed up to 20years
Secondary outcomes (1)
The correlation of genotype and phenotype
Genotype is defined by NOTCH3 pathogenic variant position and phenotype is defined by clinical types and characteristics.
Measured: From date of enrollment until the date of death from any cause, assessed up to 20years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start9 Mar 2020
- Primary completion9 Mar 2039 (estimated)
- Study completion9 Mar 2049 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CadasilStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Cai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin Cai, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310098
- Sponsor's protocol ID
- MRCTA,ECFAH of FMU [2019]244-1
- Status last verified
- Sep 2023
- First submitted
- 14 Mar 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy Registry Study
- ClinicalTrials.gov ID
- NCT04310098
- Acronym / sponsor ID
- MRCTA,ECFAH of FMU [2019]244-1
- Conditions
- Cadasil
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bin CaiUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 9 Mar 2039 (estimated)
- Study completion
- 9 Mar 2049 (estimated)
- First posted
- 17 Mar 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 aim of this study is to determine the clinical spectrum and natural progression of Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) and related disorders in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CADASIL , to optimize clinical management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CADASIL patients | – | – |
| Asymptomatic carriers of CADASIL | – | – |
| Relatives of CADASIL patients and carriers | – | – |
| Unrelated healthy controls | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed in hosipital and their's family
Key inclusion criteria (6 listed)
- Sign informed consent.
- Age>18
- Clinical diagnosis of patients with CADASIL,and confirmed by genetic test or skin biopsy
- Asymptomatic NOTCH3 mutation carriers
- Relatives of CADASIL patients or carriers
Key exclusion criteria (3 listed)
- Unable to cooperate with inspectors
- Serious systemic illness, such as heart, liver, kidney disease or major mental illness
- Contraindications for imaging examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall outcomes in CADASIL patients
Time frame: From date of enrollment until the date of death from any cause, assessed up to 20years
record the occurrence of stroke and use modified Rankin Scale (mRS) to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
1 secondary outcome
The correlation of genotype and phenotype
Time frame: From date of enrollment until the date of death from any cause, assessed up to 20years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
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 Cadasil, run by Bin Cai 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Sep 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Yi, PhD (13615039153 ext. 86, caibin929@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall outcomes in CADASIL patients (time frame: From date of enrollment until the date of death from any cause, assessed up to 20years). 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 28 Sep 2023.