- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868255
Myeloid Derived Suppressor Cells Control by Signal Regulatory Protein-alpha: Investigation in Hepatocellular Carcinoma (MDScan)
Myeloid Derived Suppressor Cells Control by SIRP-alpha: Investigation in Hepatocellular Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Nantes, France, 44093
- CHU de Nantes
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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).
|
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).
|
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).
|
Several types of samples will be used to test the effect of the drug candidate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluation of the SIRP/CD47 expression
Time Frame: 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
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isabelle ARCHAMBEAUD, Dr, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC16_0156
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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