Screening of Hepatocellular Carcinoma in Patients With Co... | NCT00190385

Studies
Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

NCT00190385

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Feb 25, 2011Estimated

Enrollment

1,200Actual

Phase

Phase 3

Conditions

Compensated Cirrhosis

Interventions

Ultrasonographic screening

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2000

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2011

Last Update Posted Date

Feb 25, 2011Estimated

Name	Class
Ministry of Health, France	OTHER_GOV
UNICANCER	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients: All consecutive patients with compensated HBV, HCV, alcohol or hemochromatosis-related cirrhosis (without any previous clinical complication including liver cancer).

Randomization: factorial: ultrasonography (3-month versus 6-month); serum alfa-fetoprotein assay (none versus 6-month).

End points: rate of small tumors (first main criteria); survival (second main criteria).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator		Procedure: Ultrasonographic screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonographic screening	Procedure	Ultrasonographic screening	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of small hepatocellular carcinoma (HCC)		6 months versus 3 months

Secondary Outcomes

Measure	Description	Time Frame
Survival		during the study
Clinical value of serum alfa-fetoprotein assay		during the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Compensated cirrhosis

Exclusion Criteria:

Antecedent of osmic acid synoviorthesis or of isotopic synoviorthesis of the studied knee
Intra-articular injection of triamcinolone hexacetonide in three months preceding the inclusion or by a different corticoid in the month preceding the inclusion
Evolutionary infectious or neoplastic pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Claude Trinchet, Pr, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Jean Verdier		Paris	Île-de-France Region	75010	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34522876	Derived	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.
25284616

ID	Term
D005355	Fibrosis
D006528	Carcinoma, Hepatocellular
D006432	Hemochromatosis

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000230	Adenocarcinoma
D002277	Carcinoma