Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis
1 other identifier
interventional
1,200
1 country
1
Brief Summary
Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors is currently recommended, but the best periodicity is unknown.This randomized trial is aimed to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2000
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFebruary 25, 2011
March 1, 2007
9 years
September 14, 2005
February 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of small hepatocellular carcinoma (HCC)
6 months versus 3 months
Secondary Outcomes (2)
Survival
during the study
Clinical value of serum alfa-fetoprotein assay
during the study
Study Arms (1)
A
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Compensated cirrhosis
You may not qualify if:
- Antecedent of osmic acid synoviorthesis or of isotopic synoviorthesis of the studied knee
- Evolutionary infectious or neoplastic pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Ministry of Health, Francecollaborator
- UNICANCERcollaborator
Study Sites (1)
Hopital Jean Verdier
Paris, Île-de-France Region, 75010, France
Related Publications (3)
Ganne-Carrie N, Nahon P, Chaffaut C, N'Kontchou G, Layese R, Audureau E, Chevret S; CIRRAL group; ANRS CO12 CirVir group. Impact of cirrhosis aetiology on incidence and prognosis of hepatocellular carcinoma diagnosed during surveillance. JHEP Rep. 2021 Mar 26;3(3):100285. doi: 10.1016/j.jhepr.2021.100285. eCollection 2021 Jun.
PMID: 34522876DERIVEDNery F, Chevret S, Condat B, de Raucourt E, Boudaoud L, Rautou PE, Plessier A, Roulot D, Chaffaut C, Bourcier V, Trinchet JC, Valla DC; Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire. Causes and consequences of portal vein thrombosis in 1,243 patients with cirrhosis: results of a longitudinal study. Hepatology. 2015 Feb;61(2):660-7. doi: 10.1002/hep.27546. Epub 2015 Jan 5.
PMID: 25284616DERIVEDTrinchet JC, Chaffaut C, Bourcier V, Degos F, Henrion J, Fontaine H, Roulot D, Mallat A, Hillaire S, Cales P, Ollivier I, Vinel JP, Mathurin P, Bronowicki JP, Vilgrain V, N'Kontchou G, Beaugrand M, Chevret S; Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire (GRETCH). Ultrasonographic surveillance of hepatocellular carcinoma in cirrhosis: a randomized trial comparing 3- and 6-month periodicities. Hepatology. 2011 Dec;54(6):1987-97. doi: 10.1002/hep.24545.
PMID: 22144108DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Claude Trinchet, Pr, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 19, 2005
Study Start
July 1, 2000
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 25, 2011
Record last verified: 2007-03