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

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ClinicalTrials.gov Identifier: NCT04766736
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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

Study Design
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Study Type : Observational
Estimated 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 : July 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2022
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Both men and women, between 18 and 85 years of age, suffering from Hepatocellular Carcinoma.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- absence of informed consent

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04766736


Contacts
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Contact: Fabien ZOULIM, Pr 4 26 10 93 55 ext +33 fabien.zoulim@chu-lyon.fr
Contact: Romain PARENT 4 72 68 19 70 ext +33 romain.parent@inserm.fr

Locations
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France
Hepatogastroenterology service of the Croix-Rousse Hospital Recruiting
Lyon, France, 69004
Contact: Fabien ZOULIM, Pr    4 26 10 93 55 ext +33    fabien.zoulim@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04766736    
Other Study ID Numbers: 69HCL19_0258
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs