NCT04690972

Brief Summary

Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
40mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress62%
Jan 2021Sep 2029

First Submitted

Initial submission to the registry

December 4, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2021

Completed
8.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2029

Expected
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

4 days

First QC Date

December 4, 2020

Last Update Submit

February 10, 2026

Conditions

Keywords

Liver diseaseEx vivo modelsSingle cellBiomarkersSpheroïds

Outcome Measures

Primary Outcomes (1)

  • Surgery for a hepato-bilio-pancreatic issue

    Patients whom hepato-bilio-pancreatic disease

    through study completion, an average of 8 year

Study Arms (3)

Hepato-bilio-pancreatic surgery

Patients whom hepato-bilio-pancreatic surgery is indicated as part of the care

Procedure: Blood sample during surgery

biopsy of the hepatic parenchyma

Patients whom a biopsy of the hepatic parenchyma, one or more hepatic nodules or a loco-regional treatment is indicated as part of the care

Procedure: Taking an additional biopsy

Viral chronic infection

Patients with a viral chronic liver disease

Diagnostic Test: Blood sample during diagnostic test

Interventions

As part of the treatment, an additional biopsy is executed and blood is drawn.

Also known as: Blood sample during biopsy
biopsy of the hepatic parenchyma

Blood sample as part of the care

Viral chronic infection

During the hepato-bilio-pancreatic surgery, blood is drawn.

Hepato-bilio-pancreatic surgery

Eligibility Criteria

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

Population with hepato-bilio-pancratic disease (tumor, viral infection, injury)

You may qualify if:

  • Patients
  • diagnosed with chronic liver disease (viral or not)
  • diagnosed with at least one liver nodule for which a biopsy is planned as part of the care
  • for hepatobiliary surgery planned as part of care
  • for locoregional treatment for HCC is indicated
  • Patients able to receive and understand information relating to the study and give their written informed consent
  • Patients affiliated to the French social security system

You may not qualify if:

  • Minor patients
  • Patients under legal protection,
  • Patients subject to legal protection or unable to express their consent,
  • Patients in a situation of social fragility,
  • Pregnant or breastfeeding woman,
  • No signing of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PU-PH, Directeur de l'UMR_S1110 Unité Inserm d'affiliation : UMR_S1110

Strasbourg, 67000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample Cohort 1 and 2 : 1 tube (10ml) of blood Cohort 3 : 10 tubes (10ml) of blood

MeSH Terms

Conditions

FibrosisLiver NeoplasmsNon-alcoholic Fatty Liver DiseaseHepatitis BHepatitis CHepatitis DLiver Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesFatty LiverBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisFlaviviridae InfectionsRNA Virus Infections

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 31, 2020

Study Start

January 14, 2021

Primary Completion

January 18, 2021

Study Completion (Estimated)

September 2, 2029

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations