- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00339521
Genetic Susceptibility to Childhood Respiratory IIlness in Mexico City
3. desember 2020 oppdatert av: National Institute of Environmental Health Sciences (NIEHS)
Genetic Susceptibility to Childhood Respiratory Illness in Mexico City
We propose to add a collection of genetic material to a clinical trial of anti-oxidant supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public pediatric hospital in Mexico City.
The anti-oxidant study has been approved by the Institutional Review Board of the National Institute of Public Health in Mexico City and is scheduled to begin in September 1998.
The purpose of this add-on study is to examine genetic polymorphisms that may be related to asthma.
Asthma cases will be compared with their parents as controls.
In partaicular, we will save the buffy coat from the blood collection being done on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial for extraction of DNA.
This part of the sample would otherwise be discarded.
In addition, we will enroll the parents of the asthmatic child as controls for the child.
From the parents, either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected.
Although our current plan is to compare the asthmatic child to the parents using statistical methods based on the "transmission disequilibrium test" because research into various family designs for candidate gene studies is rapidly evolving and various sibling control sample strategies have been discussed, we would also like to collect a genetic sample on as many of the child's siblings as possible with priority given to those closest in age.
This will enhance the future usefulness of the samples.
We anticipate enrolling approximately 200 families....
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
We propose to add a collection of genetic material to a clinical trial of anti-oxidant supplementation for the amelioration of asthma in 7-12 year olds being conducted at a public pediatric hospital in Mexico City.
The anti-oxidant study has been approved by the Institutional Review Board of the National Institute of Public Health in Mexico City and is scheduled to begin in September 1998.
The purpose of this add-on study is to examine genetic polymorphisms that may be related to asthma.
Asthma cases will be compared with their parents as controls.
In particular, we will save the buffy coat from the blood collection being done on the asthmatic child for measurements of plasma micronutrients in the anti-oxidant trial for extraction of DNA.
This part of the sample would otherwise be discarded.
In addition, we will enroll the parents of the asthmatic child as controls for the child.
From the parents, either a 10 ml blood sample or if they prefer, a sample of buccal cells will be collected.
Although our current plan is to compare the asthmatic child to the parents using statistical methods based on the "transmission disequilibrium test" because research into various family designs for candidate gene studies is rapidly evolving and various sibling control sample strategies have been discussed, we would also like to collect a genetic sample on as many of the child's siblings as possible with priority given to those closest in age.
This will enhance the future usefulness of the samples.
We anticipate enrolling approximately 200 families.
Studietype
Observasjonsmessig
Registrering (Faktiske)
2362
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Mexico City, Mexico
- Hospital Infantil de Mexico Federico Gomez
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
4 år til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Asthmatic children registered at the allergy clinic of the Pediatric Hospital Frederico Gomez in Mexico City and their biological parents.
Beskrivelse
- INCLUSION CRITERIA:
Moderate to severe asthma, ages 7-12 and residing within 5 km of a particular ambient air pollution monitoring station.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Case-Parent Triad
Childhood Asthmatics (aged 4-17) are Cases; biologic parents of cases are genetic Controls.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
To create a resource to examine genetic susceptibility to asthma in Mexico City.
Tidsramme: End of Study
|
The role of asthma candidate genes in the association between ozone exposure and asthma incidence.
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End of Study
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Stephanie London, M.D., National Institute of Environmental Health Sciences (NIEHS)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Sandford A, Weir T, Pare P. The genetics of asthma. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1749-65. doi: 10.1164/ajrccm.153.6.8665031.
- Hopes E, McDougall C, Christie G, Dewar J, Wheatley A, Hall IP, Helms PJ. Association of glutamine 27 polymorphism of beta 2 adrenoceptor with reported childhood asthma: population based study. BMJ. 1998 Feb 28;316(7132):664. doi: 10.1136/bmj.316.7132.664. No abstract available.
- Slutsky AS, Zamel N. Genetics of asthma: the University of Toronto Program. University of Toronto Genetics of Asthma Research Group. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 2):S130-2. doi: 10.1164/ajrccm.156.4.12tac-10. Erratum In: Am J Respir Crit Care Med 1998 Feb;157(2):671.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. mai 1999
Primær fullføring (Faktiske)
12. februar 2007
Studiet fullført (Faktiske)
3. desember 2020
Datoer for studieregistrering
Først innsendt
19. juni 2006
Først innsendt som oppfylte QC-kriteriene
19. juni 2006
Først lagt ut (Anslag)
21. juni 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. desember 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. desember 2020
Sist bekreftet
1. desember 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 999999028
- OH99-E-N028
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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