ClinicalTrials.gg
Not yet recruitingNCT05892822Updated Jun 7, 2023

Amyotrophic Lateral Sclerosis Registry

An observational study in Amyotrophic Lateral Sclerosis, sponsored by yilong Wang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-07.

Sponsored by yilong Wang · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study takes amyotrophic lateral sclerosis (ALS) patients as the main research object. Through collecting genetics, imaging and clinical symptoms for Exploratory research, we will construct the gene spectrum of ALS in China, explore unknown pathogenic genes, explore the characteristic image characteristics of ALS, and establish the iPSCs library of ALS, providing resources and basis for the research of pathogenesis and treatment targets of ALS.

Read the detailed description

This study is a multicenter, prospective registration study that will follow up patients with clinically confirmed and suspected amyotrophic lateral sclerosis for a period of 2 years. A total of 1000 patients will be included to dynamically observe the changes in clinical symptoms and signs, imaging, electrophysiology, biomarkers, biological samples and so on, which will construct a genetic profile of ALS in China, explore the etiology and pathogenesis, and establish an iPSCs library, provide a basis for finding treatment targets.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • Amyotrophic lateral sclerosis
03

In context

Amyotrophic Lateral Sclerosis

978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

yilong Wang is the lead sponsor of 7 studies on the registry; 7 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study aims to include an estimated 1000 ALS patients in China.

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

  • 18 years old ≤ age ≤ 80 years old;
  • Patients are diagnosed definite or probable ALS according to the Awaji diagnostic criteria;
  • Sign an form.

Exclusion criteria

Exclusion Criteria:

  • Unable to cooperate with research or complete follow-up due to geographical or other reasons.
Terms in these criteria, in plain language(1)

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.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Amyotrophic Lateral Sclerosis

    This study is an observational study without grouping.

    Other: Amyotrophic Lateral Sclerosis

Interventions

  • OtherAmyotrophic Lateral Sclerosis

    All ALS patients included in this group.

06

What researchers measure

Primary outcomes

  1. Gene Mutation Characteristics of ALS in Chinese

    Constructing a Chinese ALS genetic information database by collecting genetic information from patients.

    Time frame: day 1

  2. The disease development of ALS in the Chinese

    Record the progress of patients' clinical symptoms from baseline through 2-year follow-up.

    Time frame: month 24

Secondary outcomes

  1. Exploring the imaging characteristics of ALS in the Chinese

    Record the change of the patient's head MRI from baseline through follow-up every 3 months.

    Time frame: day 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24

  2. Establishing an iPSCs library for ALS in the Chinese

    100 fALS and clinically typical sALS were selected. Monocytes were isolated from peripheral blood collected at baseline, and Reprogramming into iPSCs to establish iPSCs library.

    Time frame: day 1

  3. Analysis of the correlation between electrophysiology characteristics and imaging characteristics of ALS in Chinese

    Record the progression of the disease from an electrophysiological and imaging perspective by conducting electromyography and head MRI every 3 months.

    Time frame: day 1, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24

07

Study locations

1 site
08

References and documents

Publications

  • Kiernan MC, Vucic S, Cheah BC, Turner MR, Eisen A, Hardiman O, Burrell JR, Zoing MC. Amyotrophic lateral sclerosis. Lancet. 2011 Mar 12;377(9769):942-55. doi: 10.1016/S0140-6736(10)61156-7. Epub 2011 Feb 4. PubMed 21296405 ↗
  • Meng L, Bian A, Jordan S, Wolff A, Shefner JM, Andrews J. Profile of medical care costs in patients with amyotrophic lateral sclerosis in the Medicare programme and under commercial insurance. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Feb;19(1-2):134-142. doi: 10.1080/21678421.2017.1363242. Epub 2017 Sep 11. PubMed 28891333 ↗
  • van Rheenen W, van der Spek RAA, Bakker MK, van Vugt JJFA, Hop PJ, Zwamborn RAJ, de Klein N, Westra HJ, Bakker OB, Deelen P, Shireby G, Hannon E, Moisse M, Baird D, Restuadi R, Dolzhenko E, Dekker AM, Gawor K, Westeneng HJ, Tazelaar GHP, van Eijk KR, Kooyman M, Byrne RP, Doherty M, Heverin M, Al Khleifat A, Iacoangeli A, Shatunov A, Ticozzi N, Cooper-Knock J, Smith BN, Gromicho M, Chandran S, Pal S, Morrison KE, Shaw PJ, Hardy J, Orrell RW, Sendtner M, Meyer T, Basak N, van der Kooi AJ, Ratti A, Fogh I, Gellera C, Lauria G, Corti S, Cereda C, Sproviero D, D'Alfonso S, Soraru G, Siciliano G, Filosto M, Padovani A, Chio A, Calvo A, Moglia C, Brunetti M, Canosa A, Grassano M, Beghi E, Pupillo E, Logroscino G, Nefussy B, Osmanovic A, Nordin A, Lerner Y, Zabari M, Gotkine M, Baloh RH, Bell S, Vourc'h P, Corcia P, Couratier P, Millecamps S, Meininger V, Salachas F, Mora Pardina JS, Assialioui A, Rojas-Garcia R, Dion PA, Ross JP, Ludolph AC, Weishaupt JH, Brenner D, Freischmidt A, Bensimon G, Brice A, Durr A, Payan CAM, Saker-Delye S, Wood NW, Topp S, Rademakers R, Tittmann L, Lieb W, Franke A, Ripke S, Braun A, Kraft J, Whiteman DC, Olsen CM, Uitterlinden AG, Hofman A, Rietschel M, Cichon S, Nothen MM, Amouyel P; SLALOM Consortium; PARALS Consortium; SLAGEN Consortium; SLAP Consortium; Traynor BJ, Singleton AB, Mitne Neto M, Cauchi RJ, Ophoff RA, Wiedau-Pazos M, Lomen-Hoerth C, van Deerlin VM, Grosskreutz J, Roediger A, Gaur N, Jork A, Barthel T, Theele E, Ilse B, Stubendorff B, Witte OW, Steinbach R, Hubner CA, Graff C, Brylev L, Fominykh V, Demeshonok V, Ataulina A, Rogelj B, Koritnik B, Zidar J, Ravnik-Glavac M, Glavac D, Stevic Z, Drory V, Povedano M, Blair IP, Kiernan MC, Benyamin B, Henderson RD, Furlong S, Mathers S, McCombe PA, Needham M, Ngo ST, Nicholson GA, Pamphlett R, Rowe DB, Steyn FJ, Williams KL, Mather KA, Sachdev PS, Henders AK, Wallace L, de Carvalho M, Pinto S, Petri S, Weber M, Rouleau GA, Silani V, Curtis CJ, Breen G, Glass JD, Brown RH Jr, Landers JE, Shaw CE, Andersen PM, Groen EJN, van Es MA, Pasterkamp RJ, Fan D, Garton FC, McRae AF, Davey Smith G, Gaunt TR, Eberle MA, Mill J, McLaughlin RL, Hardiman O, Kenna KP, Wray NR, Tsai E, Runz H, Franke L, Al-Chalabi A, Van Damme P, van den Berg LH, Veldink JH. Common and rare variant association analyses in amyotrophic lateral sclerosis identify 15 risk loci with distinct genetic architectures and neuron-specific biology. Nat Genet. 2021 Dec;53(12):1636-1648. doi: 10.1038/s41588-021-00973-1. Epub 2021 Dec 6. Erratum In: Nat Genet. 2022 Mar;54(3):361. doi: 10.1038/s41588-022-01020-3. PubMed 34873335 ↗
  • Oskarsson B, Gendron TF, Staff NP. Amyotrophic Lateral Sclerosis: An Update for 2018. Mayo Clin Proc. 2018 Nov;93(11):1617-1628. doi: 10.1016/j.mayocp.2018.04.007. Epub 2018 Jul 4. PubMed 30401437 ↗
  • Sances S, Bruijn LI, Chandran S, Eggan K, Ho R, Klim JR, Livesey MR, Lowry E, Macklis JD, Rushton D, Sadegh C, Sareen D, Wichterle H, Zhang SC, Svendsen CN. Modeling ALS with motor neurons derived from human induced pluripotent stem cells. Nat Neurosci. 2016 Apr;19(4):542-53. doi: 10.1038/nn.4273. PubMed 27021939 ↗
  • Rowe RG, Daley GQ. Induced pluripotent stem cells in disease modelling and drug discovery. Nat Rev Genet. 2019 Jul;20(7):377-388. doi: 10.1038/s41576-019-0100-z. PubMed 30737492 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2023; primary completion for Dec 2024, 18 months later.

Of 127 non-industry observational studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 125. This study's planned 18 months is below that.

Counting every sponsor, half of 136 studies reached it within 64 months; a quarter within 29 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2023
First posted
Jun 7, 2023
StartEst.
Jun 15, 2023
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Jun 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05892822
Lead sponsor
yilong Wang
Responsible party
yilong Wang (Vice-President of Beijing Tiantan Hospital,Chief Scientist of Neurology Center, Beijing Tiantan Hospital) — Sponsor-investigator
First posted
Jun 7, 2023
Start date
Jun 15, 2023 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jun 7, 2023

Study contacts

Yilong Wang, M.D.
Contact
yilong528@gmail.com
13911666571
Weiqi Chen, M.D.
Contact
weiqichen@aliyun.com
15652813380
Yilong Wang, M.D.
principal investigator · Beijing Tiantan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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