Molecular Epidemiology of Hepatitis B in Cayenne General Hospital, French Guiana

NCT04886102 | Unknown DMC

• 1 other identifier: EMOHCAY
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

In South America, the prevalence of HBV is variable but high (\> 8%) in the Amazon basin. In some areas, a third of HBsAg carriers are also infected with HDV, a major comorbidity factor. The pre-core mutations are associated with the negative HBe Ag phenotype which is associated with a more severe course. These mutations are of increasing and high frequency. French Guiana is populated by populations of African, European and Asian origins with chains of viral transmission which are not known and viruses probably of different origins with variable virulence and transmission potentials.

Conditions

Hepatitis B, Chronic; Adults

Keywords

Hepatitis B, Chronic; Hepatitis B Virus Infection; Adults; French Guiana; Hepatitis C Virus Infection; Co-infection; Chain of transmission; Epidemiology, molecular; Viral phylodynamics; Viral phylogenetics

Outcome Measures

Primary Outcomes (1)

• Hepatitis B virus (HBV) sequencing

  The mutations studied will be those relating to AgS and to the pre-core regions. The viral nucleic acids will be extracted using the Qiagen® technique on the Qiacube® machine. The HBV genotyping will be carried out by sequencing the nucleotides of a DNA segment amplified from the HBV S gene (nt 414 to nt 822, reference sequence HBV strain NC003977). In order to study the genetic proximity between the HBV strains, the samples will be subjected to whole genome sequencing based on the method of Ramachandran et al using two amplification steps. The first round of whole genome amplification will be followed by a second round of PCR nested on 6 overlapping fragments of 600bp each. A phylodynamic approach will estimate the aspects time of viral evolution. Phylogenetic trees will be produced to illustrate the genetic differences between the different types of viruses circulating in French Guiana with Mega software.

  2 years

Secondary Outcomes (2)

• Hepatitis D virus (VHD) sequencing

  2 years

• Liver function Markers

  2 years

Interventions

An additional 5 mL venous blood tube taken from patients during their routine medical check-up at the hospital OTHER

Research protocol involving the human person (Category 3 - Non-interventional research\_ not related to a health product) Serology, molecular biology, phylogenetic and phylodynamic analyzes of hepatitis B and D

Also known as: Molecular biology analyzes of hepatitis B and D, Phylogenetic and phylodynamic analyzes of hepatitis B, Phylogenetic and phylodynamic analyzes of hepatitis C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients infected with hepatitis B followed at the Cayenne hospital center (adult day hospital consultations, consultations with the infectious and tropical diseases department and hepatology B medicine consultations) Estimated size of target population: 1000

You may qualify if:

• Age ≥ 18 years old
• Person with confirmed chronic hepatitis B
• Person who does not object to their participation in the protocol
• HBV viral load\> = 500 copies / mL
• Person who has planned / is willing to have their next HBV assessment of current care taken at the Cayenne Hospital center

You may not qualify if:

• Refusal to participate
• Age \<18 years old
• Person opposing their participation in the protocol
• HBV viral load \<500 copies / mL
• Person who has not planned / been unwilling to have their next HBV assessment of current care taken at the Cayenne Hospital center

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead
• Hospital Avicenne: collaborator
• University Hospital, Montpellier: collaborator
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (1)

General Hospital of Cayenne

Cayenne, 97306, French Guiana

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

An additional 5 mL venous blood tube taken from patients during their routine medical check-up at the hospital on which the serology and molecular biology analyzes of hepatitis B and D and the phylogenetic and phylodynamic analyzes of hepatitis B will be performed

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B; Hepatitis C; Coinfection

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Mathieu NACHER, MD, PhD

  Centre Hospitalier de Cayenne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxane SCHAUB, MD

CONTACT

+594 594 39 55 96; roxane.schaub@ch-cayenne.fr

DRISP General Hospital of Cayenne

CONTACT

+594 594 39 53 85; cicec@ch-cayenne.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: May 13, 2021
• Study Start: February 11, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

FR (1)