Screening for liver fibrosis and cirrhosis in adults with hepatitis B or C
Out-of-hospital Screening of Patients With Significant Hepatic Fibrosis or Cirrhosis and Viral Hepatitis B and C
This program offers on-site FibroScan and quick hepatitis B and C tests to adults visiting a municipal health center to look for liver fibrosis or cirrhosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Bobigny and 1 other locations) |
| Trial ID | NCT06755632 on ClinicalTrials.gov |
What this trial studies
This protocol offers targeted screening for liver fibrosis and cirrhosis to adults attending a municipal health center in Seine-Saint-Denis using a portable FibroScan mini and rapid hepatitis B and C tests (TROD) performed by a traveling physician. Patients with FibroScan stiffness ≥ 9.6 kPa or a positive HCV or HBsAg rapid test are offered referral appointments to hepatology at Avicenne or Jean Verdier hospitals. Eligible participants are adults aged 18 or older with French social security coverage who provide informed consent, and common exclusions are pregnancy, lack of consent capacity, legal protection statuses, or AME coverage. The approach aims to improve case finding and timely linkage to specialist care in a high-prevalence, socioeconomically vulnerable area.
Who should consider this trial
Good fit: Adults (≥18) who are affiliated with the French social security system and attend the participating municipal health center, especially those with risk factors for liver disease or known hepatitis B or C.
Not a fit: People who are pregnant, under guardianship or court protection, lacking capacity or consent, covered by AME, hospitalized for non-research reasons, or living outside the program area may not benefit from this screening.
Why it matters
Potential benefit: If successful, the program could find more people with advanced fibrosis or cirrhosis earlier and connect them to specialist care to reduce complications.
How similar studies have performed: Other programs using FibroScan and rapid hepatitis tests in community settings have successfully increased detection and referral to hepatology, and antiviral cures for hepatitis C and suppressive therapy for hepatitis B are well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age≥18 years * Collection of signed consent * Patients affiliated to a Social Security System Exclusion Criteria: * Pregnancy or breastfeeding * Subjects under AME * Persons under court protection * Guardianship or curatorship, * Safeguard of justice * Persons under psychiatric care without their consent * Persons admitted to a health or social institution for purposes other than research, * Patients of full age under legal protection (guardianship or curatorship) * Persons unable to express their consent.
Where this trial is running
Bobigny and 1 other locations
- Avicenne Hospital — Bobigny, France (Recruiting)
- Hepatology department -Hospital Avicenne — Bobigny, France (Withdrawn)
Study contacts
- Study coordinator: Veronique GRANDO, MD-PhD
- Email: veronique.grando@aphp.fr
- Phone: 01 48 02 68 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.