ClinicalTrials.gg
RecruitingNCT04310098Updated Sep 28, 2023

CADASIL Registry Study

An observational study in Cadasil, sponsored by Bin Cai. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Bin Cai · Observational

From the registry’s dates

  • Started Mar 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 85 Years
Sex
All
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Study 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 CADASIL , to optimize clinical management.

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Conditions studied

  • Cadasil

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In context

CADASIL

33 studies on the registry are indexed under CADASIL; 18 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 168 across 22 observational studies indexed under CADASIL.

Browse CADASIL studies →

Lead sponsor

Bin Cai is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients diagnosed in hosipital and their's family

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Sign .
  2. Age>18
  3. Clinical diagnosis of patients with CADASIL,and confirmed by genetic test or skin
  4. Asymptomatic NOTCH3 mutation carriers
  5. Relatives of CADASIL patients or carriers
  6. Unrelated healthy controls

Exclusion criteria

Exclusion Criteria:

  1. Unable to cooperate with inspectors
  2. Serious systemic illness, such as heart, liver, kidney disease or major mental illness
  3. for imaging examination
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • CADASIL patients
  • Asymptomatic carriers of CADASIL
  • Relatives of CADASIL patients and carriers
  • Unrelated healthy controls
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: From date of enrollment until the date of death from any cause, assessed up to 20years

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04310098
Lead sponsor
Bin Cai
Responsible party
Bin Cai (Professor, First Affiliated Hospital of Fujian Medical University) — Sponsor-investigator
First posted
Mar 17, 2020
Start date
Mar 9, 2020
Primary completion
Mar 9, 2039 (estimated)
Completion
Mar 9, 2049 (estimated)
Last update
Sep 28, 2023

Study contacts

Lin Yi, PhD
Contact
caibin929@163.com
13615039153 ext. 86
Cai Bin, PhD
Contact
caibin929@163.com
13338413842

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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