- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02749864
Study to Evaluate the Prevalence of Hepatitis C in Spain in 2015 (PREVHEP) (PREVHEP)
Personalized Medicine in HCV Infection. A Prospective, Multicenter, Epidemiological Study to Evaluate the Prevalence of Hepatitis C Infection in Spain in 2015 (PREVHEP)
The hypothesis of this investigation stresses that the current understanding of the prevalence of HCV infection in the general population and in different subgroups will serve to lay out medium- and long-term measures for action geared toward reducing the disease burden through preventive, research, screening and therapeutic measures.
Aim: To determine the prevalence of seropositivity and chronic infection with the HCV and to analyze the associated factors. To analyze and infer different screening strategies for HCV infection based on the at-risk groups/cohorts of elevated prevalence detected. to assess the efficiency of screening strategies and the subsequent cost-effectiveness of treatment in the general population
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Design of the study: Seroepidemiological and virological study of cross-sectional population-based.
Patients and sampling: The study population has been distributed in groups according to age (20-34; 35-49; 50-74 years) and sex. In order to select a representative sample of this overall population, three Spanish regions will be selected on the basis of their different HCV-related hospitalisation rates defined as follows: high, >120 cases/100,000 inhabitants (Madrid); medium, 90-119 cases/100,000 inhabitants (Cantabria); or low, <90 cases/100,000 inhabitants (Valencia).
The participants will be selected through a random, representative sample using our two-stage conglomerate sampling with stratification of the First-Stage Units. These FSUs are made up by the Basic Health Areas (Health Centers). The Second-Stage Units are made up by the individuals. The stratification criteria used in the first stage will be the socioeconomic status-rural/urban environment. The selection of sample elements will be carried out through simple random sampling from the healthcare card database pertaining to the selected Health Centers. A sequence of random, computer-generated numbers will be obtained.
Sample size: In order to achieve an accuracy of 0.4% in the estimate of a percentage through a two-tailed 95% confidence interval, assuming the prevalences indicated by age strata in the general Spanish population (0.6%, 1.9% and 2.7% respectively), a total of 12,263 subjects distributed as follows: 1,456 aged 20-34 years, 4,476 aged 35-49 years and 6,331 aged 50-74 years.
Anticipating an uptake of 9-15%,21 following invitation via telephone, between 81,753 and 136,255 subjects distributed over the three regions needed to be contacted at random.
Recruitment method for randomized patients. Selected subjects will be called by phone by trained personnel. The subject will be invited to report for an interview in order to carry out a socio-healthcare questionnaire, a physical examination, and an analytical test. In the event the patient refuses to participate, permission shall be requested to collect minimum anonymous data for the subsequent study of possible screening biases. Patients meeting inclusion criteria and provide written informed consent to be included in the study.
Variables in the study: socio-healthcare questionnaire includes variables such as age, sex, socioeconomic status, risk factors, health habits, etc. Analytical variables (blood count, biochemistry, serologies for HBV and HCV, etc.) are collected. A Fibroscan is also performed. A cost-effectiveness of screening strategies and treatment will be analysed using a Markov model
Full duration: 21 months
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Madrid, Spania, 28222
- Hospital Universitario Puerta de Hierro-Majadahonda
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Cantabria
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Santander, Cantabria, Spania, 39008
- Hospital Universitario Marqués de Valdecilla
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spania
- Hospital Clinico Universitario de Valencia
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
General population aged 20-74 years who agree to participate when contacted by phone call after a two-stage conglomerate sampling with stratification of the First-Stage Units.
The study will be carried out in three Autonomous Communities (regions) in Spain.
Beskrivelse
Inclusion Criteria:
- Patients between 20 and 74 who have health card in each of the autonomous communities studied.
- They agree to participate, understand and give informed consent.
Exclusion Criteria:
- Do not meet the criteria above.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
A: Age 20-34 yr
No intervention Cohort of subjects aged 20-34 years old.
|
B: Age 35-49 yr
No intervention Cohort of subjects aged 35-49 years old.
|
C: Age 50-79 yr
No intervention Cohort of subjects aged 50-79 years old.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Serum Anti-HCV
Tidsramme: 1 day
|
Anti-HCV seroprevalence
|
1 day
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
HCV RNA viral load
Tidsramme: 1 day
|
Chronic HCV infection
|
1 day
|
Serum HBsAg
Tidsramme: 1 day
|
HBV portador status
|
1 day
|
Birth date
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Sex
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Nationality
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Residence time in Spain
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Educational level
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Activity and professional qualifications
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Lifestyle habit/risk factor score
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Nosocomial risk score
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
History of previous check of HCV/HBV exposure
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Sexual behaviour
Tidsramme: 1 day
|
Questionnarie about socio-economic and Health variables
|
1 day
|
Number of sexual partners
Tidsramme: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Weight (kg)
Tidsramme: 1 day
|
Weight (Anthropometric variables)
|
1 day
|
Height (cm)
Tidsramme: 1 day
|
Height (Anthropometric variables)
|
1 day
|
BMI
Tidsramme: 1 day
|
Body Mass Index (Anthropometric variables)
|
1 day
|
Abdominal perimeter (cm)
Tidsramme: 1 day
|
Abdominal perimeter (Anthropometric variables)
|
1 day
|
Waist perimeter (cm)
Tidsramme: 1 day
|
Waist perimeter (Anthropometric variables)
|
1 day
|
Blood pressure (mmHg)
Tidsramme: 1 day
|
Blood pressure
|
1 day
|
ALT
Tidsramme: 1 day
|
Liver function tests
|
1 day
|
AST
Tidsramme: 1 day
|
Liver function tests
|
1 day
|
Alkaline Phosphatase (AP)
Tidsramme: 1 day
|
Liver function tests
|
1 day
|
GGT (Gammaglutamyl transferase)
Tidsramme: 1 day
|
Liver function tests
|
1 day
|
Bilirubin
Tidsramme: 1 day
|
Liver function tests
|
1 day
|
Serum Albumin
Tidsramme: 1 day
|
Biochemistry parameters
|
1 day
|
Total Cholesterol
Tidsramme: 1 day
|
Biochemistry parameters
|
1 day
|
LDL Cholesterol
Tidsramme: 1 day
|
Biochemistry parameters
|
1 day
|
HDL Cholesterol
Tidsramme: 1 day
|
Biochemistry parameters
|
1 day
|
Triglycerides
Tidsramme: 1 day
|
Biochemistry parameters
|
1 day
|
White blood cell count (WBC or leukocyte count)
Tidsramme: 1 day
|
CBC
|
1 day
|
Hemoglobin
Tidsramme: 1 day
|
CBC
|
1 day
|
Platelets
Tidsramme: 1 day
|
CBC
|
1 day
|
INR
Tidsramme: 1 day
|
International Normalized Ratio
|
1 day
|
kPa in Fibroscan
Tidsramme: 1 day
|
Liver stiffness
|
1 day
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Javier Crespo García, MDPhD, Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria
- Hovedetterforsker: Jose L Calleja, MDPhD, Head of Gastroenterology and Hepatology at Hospital Universitario Puerta de Hierro-Majadahonda
- Hovedetterforsker: Miguel A Serra, MDPhD, Gastroenterology and Hepatology Department at Hospital Clínico U. de Valencia
Publikasjoner og nyttige lenker
Generelle publikasjoner
- McGarry LJ, Pawar VS, Panchmatia HR, Rubin JL, Davis GL, Younossi ZM, Capretta JC, O'Grady MJ, Weinstein MC. Economic model of a birth cohort screening program for hepatitis C virus. Hepatology. 2012 May;55(5):1344-55. doi: 10.1002/hep.25510. Epub 2012 Mar 18.
- Bruguera M, Forns X. [Hepatitis C in Spain]. Med Clin (Barc). 2006 Jun 17;127(3):113-7. doi: 10.1157/13090276. Spanish.
- Ditah I, Ditah F, Devaki P, Ewelukwa O, Ditah C, Njei B, Luma HN, Charlton M. The changing epidemiology of hepatitis C virus infection in the United States: National Health and Nutrition Examination Survey 2001 through 2010. J Hepatol. 2014 Apr;60(4):691-8. doi: 10.1016/j.jhep.2013.11.014. Epub 2013 Nov 27.
- Llop E, Iruzubieta P, Perello C, Fernandez Carrillo C, Cabezas J, Escudero MD, Gonzalez M, Hernandez Conde M, Puchades L, Arias-Loste MT, Serra MA, Crespo J, Calleja JL. High liver stiffness values by transient elastography related to metabolic syndrome and harmful alcohol use in a large Spanish cohort. United European Gastroenterol J. 2021 Oct;9(8):892-902. doi: 10.1002/ueg2.12109. Epub 2021 Jun 2.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Hepadnaviridae-infeksjoner
- DNA-virusinfeksjoner
- Enterovirusinfeksjoner
- Picornaviridae-infeksjoner
- Hepatitt B
- Hepatitt
- Hepatitt A-virus
- Hepatitt C
Andre studie-ID-numre
- JCG-PREVHEP-2015-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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