NCT04766736

Brief Summary

Netrin-1 is a dependence receptor ligand participating in the pathology of several cancer types. It is up-regulated in chronic liver diseases, cirrhosis and HCC. We hypothesize that netrin-1 may play a detrimental role in HCC. The goal of this project is to characterize netrin-1 signals in HCC samples with ad hoc controls, to investigate the benefit of capturing netrin-1 in preclinical models of HCC and to try to define patients groups the most likely to benefit from this targeting approach in the clinic.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

February 19, 2021

Last Update Submit

February 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Netrin-1 expression patterns in HCC samples

    Netrin-1 expression levels will be quantified by immunoblotting with ad hoc internal standards. Positivity threshold by IHC will be evaluated using ad hoc positive and negative control tissues. The densitometry approach will be used.

    Outcome measure is to be performed after surgery of the tumors (at least 1 year later). It has no impact on the patient's care.

Study Arms (2)

Tumors (T) samples of various etiologies (HBV, HCV, NASH, alcool)

The combination of the Tumors status of the sample combined with its etiology ((HBV, HCV, NASH, alcool)

Procedure: Quantification of netrin-1 signals by antibody-based approaches

Non Tumors (NT) samples of various etiologies (HBV, HCV, NASH, alcool)

The combination of the Non Tumors status of the sample combined with its etiology ((HBV, HCV, NASH, alcool)

Procedure: Quantification of netrin-1 signals by antibody-based approaches

Interventions

Samples have been obtained upon curative surgery without any other therapy administered and subsequently characterized by pathologists after FFPE inclusion.

Non Tumors (NT) samples of various etiologies (HBV, HCV, NASH, alcool)Tumors (T) samples of various etiologies (HBV, HCV, NASH, alcool)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Both men and women, between 18 and 85 years of age, suffering from Hepatocellular Carcinoma.

You may qualify if:

  • any patient suffering from HCC
  • age \>18
  • informed consent provided

You may not qualify if:

  • \- absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatogastroenterology service of the Croix-Rousse Hospital

Lyon, 69004, France

RECRUITING

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 23, 2021

Study Start

July 1, 2019

Primary Completion

June 30, 2021

Study Completion

December 31, 2022

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations