Netrin-1 & Hepatocellular Carcinoma HCC (HCC-Net)

February 19, 2021 updated by: Hospices Civils de Lyon

Netrin-1 in Hepatocellular Carcinoma: Pathology, Preclinical Targeting, and Definition of Eligibility Criteria for Phase 1 Trials

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Recruiting
        • Hepatogastroenterology service of the Croix-Rousse Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

- absence of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
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
Samples have been obtained upon curative surgery without any other therapy administered and subsequently characterized by pathologists after FFPE inclusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Netrin-1 expression patterns in HCC samples
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0258

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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