- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00005682
Aplastic Anemia Epidemiology: Incidence and Case-control
Přehled studie
Postavení
Podmínky
Detailní popis
BACKGROUND:
Aplastic anemia, a form of bone marrow failure, is a disease of largely unknown cause, except for the rare situations involving high doses of radiation. Many agents have been mentioned in case reports to be associated with the development of aplastic anemia and include drugs, chemicals, pesticides, radiation, and viral infection. Of these, chloramphenicol, phenylbutazone, and insecticides are most frequently reported. In the United States and other developed countries the disease prevalence is so low that too few cases occur to make an epidemiological study in a single city logistically feasible. The Bangkok hospitalization rate for aplastic anemia was sufficient to conduct a case-control study. Also, a study conducted in this locale provided information on drugs and chemicals not commonly used in developed countries.
DESIGN NARRATIVE:
All aplastic anemia cases in metropolitan Bangkok were located and verified in the forty hospitals that agreed to participate in the study. Incidence rates were calculated by age group and sex. In the case-control study, interviews were used to obtain comprehensive histories of drug, chemical, pesticide, radiation, viral infections, and other exposures, along with relevant demographic and medical history information in order to examine the association between and test hypotheses regarding suspected hazards and to estimate the risks of developing aplastic anemia. The basic epidemiologic features of aplastic anemia were described by characterizing these patients in terms of standard demographic variables, age, race, sex, and medical history. The degree of association between viral hepatitis and the development of aplastic anemia was estimated.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Typ studie
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Studijní plán
Jak je studie koncipována?
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Paul Leaverton
- Samuel Shapiro
Publikace a užitečné odkazy
Obecné publikace
- Issaragrisil S, Kaufman DW, Anderson TE, Chansung K, Thamprasit T, Sirijirachai J, Piankijagum A, Porapakham Y, Vannasaeng S, Leaverton PE, et al. An association of aplastic anaemia in Thailand with low socioeconomic status. Aplastic Anemia Study Group. Br J Haematol. 1995 Sep;91(1):80-4. doi: 10.1111/j.1365-2141.1995.tb05248.x.
- Hibbs JR, Issaragrisil S, Young NS. High prevalence of hepatitis C viremia among aplastic anemia patients and controls from Thailand. Am J Trop Med Hyg. 1992 May;46(5):564-70. doi: 10.4269/ajtmh.1992.46.564.
- Issaragrisil S, Sriratanasatavorn C, Piankijagum A, Vannasaeng S, Porapakkham Y, Leaverton PE, Kaufman DW, Anderson TE, Shapiro S, Young NS. Incidence of aplastic anemia in Bangkok. The Aplastic Anemia Study Group. Blood. 1991 May 15;77(10):2166-8.
- Kaufman DW, Issaragrisil S, Anderson T, Chansung K, Thamprasit T, Sirijirachai J, Piankijagum A, Porapakkham Y, Vannasaeng S, Leaverton PE, Shapiro S, Young NS. Use of household pesticides and the risk of aplastic anaemia in Thailand. The Aplastic Anemia Study Group. Int J Epidemiol. 1997 Jun;26(3):643-50. doi: 10.1093/ije/26.3.643.
- Issaragrisil S, Kaufman DW, Anderson T, Chansung K, Thamprasit T, Sirijirachai J, Piankijagum A, Porapakkham Y, Vannasaeng S, Leaverton PE, Shapiro S, Young NS. Low drug attributability of aplastic anemia in Thailand. The Aplastic Anemia Study Group. Blood. 1997 Jun 1;89(11):4034-9.
- Issaragrisil S, Kaufman D, Thongput A, Chansung K, Thamprasit T, Piankijagum A, Anderson T, Shapiro S, Leaverton P, Young NS. Association of seropositivity for hepatitis viruses and aplastic anemia in Thailand. Hepatology. 1997 May;25(5):1255-7. doi: 10.1002/hep.510250532.
- Issaragrisil S, Kaufman DW, Anderson T. Incidence and non-drug aetiologies of aplastic anaemia in Thailand. The Thai Aplastic Anaemia Study Group. Eur J Haematol Suppl. 1996;60:31-4. doi: 10.1111/j.1600-0609.1996.tb01642.x.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 3008
- R01HL035068 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .