HCC-Net: Netrin-1 & Hepatocellular Carcinoma HCC

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04766736

Collaborator

(none)

320

Enrollment

Location

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HCC	Procedure: Quantification of netrin-1 signals by antibody-based approaches

Study Design

Study Type:

Observational

Anticipated Enrollment :

320 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Netrin-1 expression patterns in HCC samples [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

any patient suffering from HCC
age >18
informed consent provided

Exclusion Criteria:

absence of informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hepatogastroenterology service of the Croix-Rousse Hospital	Lyon		France	69004

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04766736

Other Study ID Numbers:

69HCL19_0258

First Posted:

Feb 23, 2021

Last Update Posted:

Feb 23, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Antibodies

Study Results

No Results Posted as of Feb 23, 2021