Amyotrophic Lateral SclerosisChALSRNCT04328675
Registration Study of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
An observational study of Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
A multi-center registration study of natural history and clinical characteristics of ALS in mainland China Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 4,752 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2020to 20 Mar 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the criteria will be enrolled from multi-centers in mainland China.
Who may be able to join
- Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria
- Age: 18-70 years
Who cannot join
- Refuse to cooperate or reject the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Dongsheng Fan, +861082265032, dsfan@sina.com
About this study
Official title: Registration Study of Natural History and Clinical Characteristics of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
A multi-center registration study of natural history and clinical characteristics of ALS in mainland China
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative disease of unknown etiology that is currently incurable. This study is a national multi-center registration study. The study collects general information of ALS patients including medical history, disease characteristics, clinical treatment data, and patient information for different visits in different centers. The aim of the study is: a) describe the distribution of ALS in mainland China(explore the differences in the number of ALS at different times, different regions, and different populations) and further find the reasons that affect the distribution of ALS, b) study the development of ALS in mainland China and the corresponding changes in the characteristics of the disease, c) explore factors that influence the prognosis of ALS.
- Conditions
- Amyotrophic Lateral Sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Survival
The length of time from the date of diagnosis to patient death or tracheotomy or ventilator-assisted breathing.
Measured: through study completion, an average of 3 month
Secondary outcomes (5)
Overall Survival
The length of time from the date of diagnosis to patient death due to any cause or the last confirmed survival.
Measured: through study completion, an average of 3 month
Rate of disease progression
The slope of decline of the ALS Functional Rating Scale-Revised (ALSFRS-R) score from the diagnosis time to the follow-up time. ALSFRS-R values from 0 to 48 and it implies better outcome when it is higher.
Measured: through study completion, an average of 3 month
Rate of Weight decline
The slope of decline of weight
Measured: through study completion, an average of 3 month
Rate of BMI decline
The slope of decline of BMI
Measured: through study completion, an average of 3 month
Rate of Forced Vital Capacity (FVC)
The slope of decline of Forced Vital Capacity (FVC) to assess the respiratory function.
Measured: through study completion, an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start20 Mar 2020
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,752 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongsheng Fan, MD, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328675
- Sponsor's protocol ID
- FDongsheng-81873784
- Acronym
- ChALSR
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He J, Fu JY, Chen L, He J, Dang J, Zou Z, Ma S, Li N, Fan D. Multicentre, prospective registry study of amyotrophic lateral sclerosis in mainland China (CHALSR): study protocol. BMJ Open. 2020 Dec 4;10(12):e042603. doi: 10.1136/bmjopen-2020-042603.
PubMed 33277290
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration Study of Natural History and Clinical Characteristics of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
- ClinicalTrials.gov ID
- NCT04328675
- Acronym / sponsor ID
- ChALSR / FDongsheng-81873784
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,752 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 31 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.
A multi-center registration study of natural history and clinical characteristics of ALS in mainland China
Detailed description
Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative disease of unknown etiology that is currently incurable. This study is a national multi-center registration study. The study collects general information of ALS patients including medical history, disease characteristics, clinical treatment data, and patient information for different visits in different centers. The aim of the study is: a) describe the distribution of ALS in mainland China(explore the differences in the number of ALS at different times, different regions, and different populations) and further find the reasons that affect the distribution of ALS, b) study the development of ALS in mainland China and the corresponding changes in the characteristics of the disease, c) explore factors that influence the prognosis of ALS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the criteria will be enrolled from multi-centers in mainland China.
Key inclusion criteria (2 listed)
- Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria
- Age: 18-70 years
Key exclusion criteria (1 listed)
- Refuse to cooperate or reject the informed consent
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
Effective Survival
Time frame: through study completion, an average of 3 month
The length of time from the date of diagnosis to patient death or tracheotomy or ventilator-assisted breathing.
5 secondary outcomes
Overall Survival
Time frame: through study completion, an average of 3 month
Rate of disease progression
Time frame: through study completion, an average of 3 month
Rate of Weight decline
Time frame: through study completion, an average of 3 month
Rate of BMI decline
Time frame: through study completion, an average of 3 month
Rate of Forced Vital Capacity (FVC)
Time frame: through study completion, an average of 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Derived from this study: PubMed 33277290He J, Fu JY, Chen L, He J, Dang J, Zou Z, Ma S, Li N, Fan D. Multicentre, prospective registry study of amyotrophic lateral sclerosis in mainland China (CHALSR): study protocol. BMJ Open. 2020 Dec 4;10(12):e042603. doi: 10.1136/bmjopen-2020-042603.
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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. This study is not recruiting at the moment.
Dongsheng Fan, MD, PhD principal investigator
Peking University Third Hospital
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 Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongsheng Fan, MD, PhD (+86-15611908107, dsfan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Survival (time frame: through study completion, an average of 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04328675, which also lists 1 linked publication.
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 Apr 2020.