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

NCT02868255 | Completed

• 1 other identifier: RC16_0156
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Biobank analyses; Effect evaluation of the drug; patient-derived cells; SIRPα/CD47 expression

Outcome Measures

Primary Outcomes (1)

• evaluation of the SIRP/CD47 expression

  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

Study Arms (3)

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

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

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

Interventions

Collection of human samples PROCEDURE

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

Ascites; Resections; blood samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Several types of samples will be used to test the effect of the drug candidate: 30 inflammatory ascites of HCC patients, 30 HCC resections (both from CHU de Nantes), 30 HCC patient blood samples.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and ascites will be analyzed for various cell populations by flow cytometry (different myeloid subsets including polymorphonuclear cells, MDSC and monocytes, T cell sub-populations including Tregs, CD8 and CD4 T cells, , B cells, and immature and mature NK cell). Myeloid infiltrate will be also evaluated by immunochemistry staining of CD68, CD163, CD206 and SIRPα of HCCs from the tumour bank.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Isabelle ARCHAMBEAUD, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: August 16, 2016
• Study Start: January 3, 2016
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: June 24, 2026

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)