- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00341861
Interdisciplinary Case-Control Study of Bladder Cancer in Spain
19. oktober 2020 opdateret af: National Cancer Institute (NCI)
The incidence rate of bladder cancer in the Barcelona area of Spain is almost identical to that of the U.S. Cigarette smoking has been identified as the most significant risk factor for bladder cancer, followed by occupational exposures to chemicals such as aromatic amines and their derivatives, diesel exhaust, oil mist, pesticides, and polynuclear aromatic hydrocarbons.
A variety of non-occupational exposures have been suggested as potential risk factors as well, including smoking black vs. blond tobacco, dietary factors, certain medications and medical conditions, chlorination by-products in drinking water, and fluid intake.
Various genetic polymorphisms also appear to affect bladder cancer risk.
Research is needed to further explore hypotheses generated by previous etiologic studies of bladder cancer.
An on-going study of bladder cancer survival by the Institut Municipal d'Investigacio Medica in Spain provides an excellent opportunity for NCI to perform such research.
NCI will build upon the ongoing study by funding an interdisciplinary case-control component to evaluate bladder cancer risk in relation to various external factors (e.g., occupational and environmental exposure) and host factors (e.g., genetic susceptibility markers, and early effect markers).
This hospital-based case-control study will involve personal interviews using a state-of-the-art, computer assisted technique, and collection of blood and toenail samples from participants.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The incidence rate of bladder cancer in the Barcelona area of Spain is almost identical to that of the U.S. Cigarette smoking has been identified as the most significant risk factor for bladder cancer, followed by occupational exposures to chemicals such as aromatic amines and their derivatives, diesel exhaust, oil mist, pesticides, and polynuclear aromatic hydrocarbons.
A variety of non-occupational exposures have been suggested as potential risk factors as well, including smoking black vs. blond tobacco, dietary factors, certain medications and medical conditions, chlorination by-products in drinking water, and fluid intake.
Various genetic polymorphisms also appear to affect bladder cancer risk.
Research is needed to further explore hypotheses generated by previous etiologic studies of bladder cancer.
An ongoing study of bladder cancer survival by the Institut Municipal d'Investigacio Medica in Spain provides an excellent opportunity for NCI to perform such research.
NCI will build upon the ongoing study by funding an interdisciplinary case-control component to evaluate bladder cancer risk in relation to various external factors (e.g., occupational and environmental exposure) and host factors (e.g., genetic susceptibility marker, and early effect markers).
This hospital-based case-control study will involve personal interviews using a state-of-the-art, computer-assisted technique, and collection of blood and toenail samples from participants.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2925
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Barcelona, Spanien
- Institut Municipal d'Investigacio Medica
-
-
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
21 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
This is a hospital-based case-control study.
Beskrivelse
- INCLUSION CRITERIA:
All histologically confirmed cases of carcinoma of the bladder including carcinoma in situ at the 21 centers.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Bladder Cancer
Tidsramme: 1998-2000
|
Incident bladder cancer
|
1998-2000
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Debra Silverman, D.Sc., National Cancer Institute (NCI)
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Agundez JA, Martinez C, Olivera M, Ledesma MC, Ladero JM, Benitez J. Molecular analysis of the arylamine N-acetyltransferase polymorphism in a Spanish population. Clin Pharmacol Ther. 1994 Aug;56(2):202-9. doi: 10.1038/clpt.1994.124.
- Babu SR, Lakshmi VM, Huang GP, Zenser TV, Davis BB. Glucuronide conjugates of 4-aminobiphenyl and its N-hydroxy metabolites. pH stability and synthesis by human and dog liver. Biochem Pharmacol. 1996 Jun 28;51(12):1679-85. doi: 10.1016/0006-2952(96)00165-7.
- Badawi AF, Hirvonen A, Bell DA, Lang NP, Kadlubar FF. Role of aromatic amine acetyltransferases, NAT1 and NAT2, in carcinogen-DNA adduct formation in the human urinary bladder. Cancer Res. 1995 Nov 15;55(22):5230-7.
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)
1. september 1998
Primær færdiggørelse (Faktiske)
4. december 2012
Studieafslutning (Faktiske)
14. oktober 2020
Datoer for studieregistrering
Først indsendt
19. juni 2006
Først indsendt, der opfyldte QC-kriterier
19. juni 2006
Først opslået (Skøn)
21. juni 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 999999038
- OH99-C-N038
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 .