UNderstanding the Causes Of Idiopathic Scoliosis Through the Longitudinal Analysis of Proteomic Markers: the UNCOIL Study (UNCOIL)
4. juni 2026 opdateret af: University of Colorado, Denver
The goal of this observational study is to find clinical, demographic, and protein biomarkers that scoliosis progression (scoliosis curve increases) and/or differ between participants with scoliosis versus those without scoliosis. We aim to answer the following questions:
- Are age, sex, skeletal maturity, and family history associated with scoliosis curve progression?
- Do protein levels differ between progressive and non-progressive cases?
- Do protein levels change between baseline and follow-up visits in progressive and non-progressive scoliosis cases?
- Do proteins differ between participants with AIS vs those without AIS?
- Do proteins or change in proteins differ between participants with AIS vs those with scoliosis secondary to neuromuscular conditions.
Participants will:
- Participate in two research visits 6-12 months apart at a Children's Hospital Colorado location.
- Participate in a blood draw at each study visit to collect about 3 tablespoons of blood.
- Fill out surveys yearly regarding new medical visits, pain, physical function, anxiety and depression, medical and family history, and current medications.
Studieoversigt
Status
Rekruttering
Undersøgelsestype
Observationel
Tilmelding (Anslået)
500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Siera R Rossi, B.S.
- Telefonnummer: 720-777-1050
- E-mail: siera.rossi@cuanschutz.edu
Undersøgelse Kontakt Backup
- Navn: Patrick Carry, PhD
- E-mail: patrick.carry@cuanschutz.edu
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- Children's Hospital Colorado Anschutz
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Scoliosis patients will be recruited from a Children's Hospital Colorado spine clinic during a routine visit for their scoliosis.
Controls will be recruited from a Children's Hospital Colorado spine clinic for those who were suspected to have scoliosis with spinal curvature <10 degrees, or from a Children's Hospital Colorado sports clinic seen for a musculoskeletal injury or condition.
Beskrivelse
Inclusion Criteria:
- Patients 10-17 years old with idiopathic or neuromuscular scoliosis with a cobb angle of 10-50°
Exclusion Criteria:
- Children diagnosed with certain genetic conditions that affect the bones or muscles (Turner syndrome, down syndrome, Marfan syndrome, osteogenesis imperfecta, muscular dystrophy, Ehlers-Danlos syndrome, VATER/VACTERL syndrome, Rett syndrome, Prader Willi syndrome, or Angelman syndrome)
- Patients with congenital scoliosis, early onset scoliosis (diagnosed before 9 years old), or those who have spine surgery scheduled prior to the first study visit
- Patients whose spinal curve is >50 degrees
- Those taking medications that may influence protein expression (baclofen, prednisone/corticosteroids, antiepileptic medications, diazepam, tizanidine, and/or dantrolene)
- Patients who are pregnant
- Patients with neurocognitive disorders who are non-verbal and/or non-ambulatory
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Scoliosis cases
Participants with clinician diagnosed adolescent idiopathic scoliosis, defined as Cobb angle >=10 degrees with rotation.
|
|
Controls
Participants without adolescent idiopathic scoliosis, described as a spinal curvature (Cobb angle) of <10 degrees.
|
|
Neuromuscular scoliosis
Participants with physician confirmed scoliosis, defined as Cobb angle >=10 degrees, secondary to a neuromuscular condition.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in curve severity
Tidsramme: Baseline and 6-12 months
|
The change in Cobb angle of the primary scoliosis curve between the baseline and the 6-12 month visit will be quantified.
|
Baseline and 6-12 months
|
|
Curve progression
Tidsramme: 6 to 12 months
|
Curve progression will be defined as an increase in Cobb angle between the baseline and 6-12 month follow-up visit of >=6 degrees and/or need for spine surgery or other invasive surgical intervention.
|
6 to 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Patrick Carry, PhD, University of Colorado, Denver
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. december 2024
Primær færdiggørelse (Anslået)
1. december 2029
Studieafslutning (Anslået)
1. december 2031
Datoer for studieregistrering
Først indsendt
4. juni 2026
Først indsendt, der opfyldte QC-kriterier
4. juni 2026
Først opslået (Faktiske)
9. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 24-0316
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Due to collection of genetics and sensitive medical data, we do not plan on sharing individual level data with other researchers at this time.
While there is no current plan to share IPD, data may be made available in the future if required by funding agencies or sponsoring organizations, and in accordance with applicable regulations, institutional policies, and participant consent.
Any data shared will be de-identified to protect participant privacy and confidentiality.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .