NCT06023745

Brief Summary

Find a possible association between Fibronectin type Ⅲ domain containing protein 5 \\ Irsin (FNDC5 rs3480) gene single nucleotide polymorphism with chronic hepatitis B and the distribution of its alleles, in relation to many clinical parameters of the chronic hepatitis B group.

  • Asses the correlation between IL-35 serum level and the risk of chronic hepatitis B.
  • Asses the correlation between SOD serum level and the risk of chronic hepatitis B.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

July 17, 2023

Last Update Submit

September 4, 2023

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

  • genotyping of Fibronectin Type Ⅲ Domain Containing Protein 5 \ Irsin (FNDC5 rs3480)

    study gene polymorphism of irsin in chronic hepatitis b patients

    2 months

  • measure of il 35 in serum

    il 35 level in serum of chronic hepatitis b pTIENTS

    2 months

Study Arms (2)

case

30 patients diagnosed as a clinical disease of CHB according to the diagnostic criteria of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA level, biochemical liver function, and ultrasonography

Genetic: genotyping

control

healthy volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities based on physical examination

Genetic: genotyping

Interventions

genotypingGENETIC

Genotyping. Measurement of SOD serum level. Measurement of IL-35 serum level.

casecontrol

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted on 50 patients 30 patients diagnosed as a clinical disease of CHB according to the diagnostic criteria of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA level, biochemical liver function, and ultrasonography (15) A control group of 30 healthy volunteers with negativity for HBsAg, anti- HCV and anti-HIV and with no abnormalities based on physical examination

You may qualify if:

  • patients diagnosed as a clinical disease of CHB according to the diagnostic criteria of CHB based on, HBsAg, HBeAg serostatus ,HBV DNA level, biochemical liver function, and ultrasonography

You may not qualify if:

  • The chronic HBV patients on antiviral therapy will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Eskandari E, Metanat M, Pahlevani E, Nakhzari-Khodakheir T. Association between TGFbeta1 polymorphisms and chronic hepatitis B infection in an Iranian population. Rev Soc Bras Med Trop. 2017 May-Jun;50(3):301-308. doi: 10.1590/0037-8682-0266-2016.

    PMID: 28700046BACKGROUND

  • Blackburn EH. Telomeres and telomerase: the means to the end (Nobel lecture). Angew Chem Int Ed Engl. 2010 Oct 4;49(41):7405-21. doi: 10.1002/anie.201002387. No abstract available.

    PMID: 20821774BACKGROUND

  • Nowinska K, Jablonska K, Ciesielska U, Piotrowska A, Haczkiewicz-Lesniak K, Pawelczyk K, Podhorska-Okolow M, Dziegiel P. Association of Irisin/FNDC5 with ERRalpha and PGC-1alpha Expression in NSCLC. Int J Mol Sci. 2022 Nov 17;23(22):14204. doi: 10.3390/ijms232214204.

    PMID: 36430689BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Genotype

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Central Study Contacts

Shimaa Badawy Hemdan, lecturer

CONTACT

01115894759shimaabadwy@med.sohag.edu.eg

Shimaa badawy Hemdan, lecturer

CONTACT

01003079646shimaabadwy@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of medical biochemistry

Study Record Dates

First Submitted

July 17, 2023

First Posted

September 5, 2023

Study Start

July 20, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 5, 2023

Record last verified: 2023-09

Locations

EG(1)