NCT03071458

Brief Summary

The MUTHEC project aims to describe the mutational and transcriptomic landscape of HCC treated by curative treatments (resection, radio frequency ablation, transplantation) as well as advanced HCC together with the analysis of circulating tumor DNA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
808

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2008

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
Last Updated

December 10, 2025

Status Verified

March 1, 2017

Enrollment Period

7.3 years

First QC Date

January 2, 2017

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Genetic and transcriptomic landscape

    Identification of the main genetic driver and transcriptomic subgroups among a large panel of HCC

    Up to 3 years

Secondary Outcomes (3)

  • Translation in immunohistochemical markers

    Up to 3 years

  • Detection and sequencing of circulating tumor DNA as a liquid biopsy in HCC

    Up to 3 years

  • Validation of the molecular classification by integrative analysis

    Up to 3 years

Study Arms (1)

Patients with HCC

The cohort is composed of patients with HCC with available tumor and non tumor samples collected retrospectively. These patients have HCC of different stages (localized and advanced stages) It is an observational retrospective study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with hepatocellular carcinoma

You may qualify if:

  • Written consent of the patient according to the French Law: the French Liver Biobanks network - AFAQ NF S96-900 and Hepatobio bank
  • Histologically proven hepatocellular carcinoma
  • Available frozen samples
  • HCC assessible to a curative treatment (Treated by resection, liver transplantation, radio frequency ablation) or advanced HCC with available biopsy

You may not qualify if:

  • Less than 18 years old
  • Pregnancy at the date of the sample
  • Parafinn embedded tissue only available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INSERM

Paris, 75010, France

Location

Related Publications (1)

  • Blaise L, Ziol M, Campani C, Ganne-Carrie N, Nahon P, Nkontchou G, Zucman-Rossi J, Del Pozo L, Barget N, Boros C, Desjonqueres E, Demory A, Grando V, Pescatori L, Seror O, Sutter O, Nault JC. Utility of tumor and non-tumor biopsies during percutaneous radiofrequency ablation for hepatocellular carcinoma. JHEP Rep. 2025 Apr 22;7(9):101430. doi: 10.1016/j.jhepr.2025.101430. eCollection 2025 Sep.

Biospecimen

Retention: SAMPLES WITH DNA

224 tumor (HCC) and 224 non tumor samples from liver transplantation 129 tumor (HCC) and 129 non tumor samples from radio frequency ablation 342 tumor (HCC) and 342 non tumor samples from liver resection 40 tumor (HCC) and 35 non tumor samples from biopsies of advanced HCC 277 plasmas of 78 patients for circulating tumor DNA analysis

MeSH Terms

Conditions

Carcinoma, HepatocellularFibrosis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • jessica zucman-rossi, Md,Phd

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR
  • jean-charles Nault

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2017

First Posted

March 7, 2017

Study Start

January 1, 2008

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 10, 2025

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations