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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02868255

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Enrollment

34.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: Collection of human samples

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Myeloid Derived Suppressor Cells Control by SIRP-alpha: Investigation in Hepatocellular Carcinoma

Actual Study Start Date :

Jan 3, 2016

Actual Primary Completion Date :

Nov 30, 2018

Actual Study Completion Date :

Nov 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Ascites 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).	Procedure: Collection of human samples Several types of samples will be used to test the effect of the drug candidate
Resections 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).	Procedure: Collection of human samples Several types of samples will be used to test the effect of the drug candidate
blood 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).	Procedure: Collection of human samples Several types of samples will be used to test the effect of the drug candidate

Arm

Intervention/Treatment

Ascites

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).

Procedure: Collection of human samples

Several types of samples will be used to test the effect of the drug candidate

Resections

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).

Procedure: Collection of human samples

Several types of samples will be used to test the effect of the drug candidate

blood 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).

Procedure: Collection of human samples

Several types of samples will be used to test the effect of the drug candidate

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nantes University Hospital
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator: Isabelle ARCHAMBEAUD, Dr, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT02868255

Other Study ID Numbers:

RC16_0156

First Posted:

Aug 16, 2016

Last Update Posted:

Sep 13, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Nantes University Hospital

Biobank analyses

Effect evaluation of the drug

patient-derived cells

SIRPα/CD47 expression

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Sep 13, 2021