Myeloid Derived Suppressor Cells Control by Signal Regulatory Protein-alpha: Investigation in Hepatocellular Carcinoma

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Collection of human samples

• Registration Number: NCT02868255
• Lead Sponsor: Nantes University Hospital

Brief Summary

project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as a new immunotherapy strategy in cancer.

Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal Regulatory Protein (hSIRP) Ab on various cellular types from patients and healthy volunteers.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-01-03
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-16
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• adult
• HCC patients (all BCLC stages accepted)
• patient consent for the use of their biological samples

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Exclusion Criteria

• patient with other cancers
• hepatitis C or B positive
• HCC treatment by chemo-embolization under 3 months
• under Sorafenib treatment within the month prior to collection
• underage or under guardianship patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ascites	Collection of human samples	30 inflammatory ascites of HCC patients (Collection of human samples ) Ascites will be selected only from HCC patients with an elevated protein level (ie inflammatory ascites) Puncture of ascites will be collected by paracentesis on HCC or ovarian cancer patients during their routine care These biological samples are affiliated with the biobank "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399).
blood samples	Collection of human samples	blood samples (Collection of human samples )will be collected prospectively for complementary functional analysis of peripheral These biological samples are affiliated with the biocollection "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399).
Resections	Collection of human samples	30 HCC resections (Collection of human samples ) Fragment of resected HCC will be obtained after surgery and histological analysis will be performed by the anatomo-pathology service These biological samples are affiliated with the biobank "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399).

Primary Outcome Measures

Name	Time	Method
evaluation of the SIRP/CD47 expression	baseline	samples harvested from HCC and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-hSIRP Ab on various cellular types from patients