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Organoids Derived From Induced-Pluripotent Stem Cells (iPS) From Patients With High Grade Astrocytoma (GLIOMANOID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03971812
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

The objective of this study research proposal is to model human gliomagenesis using 3-Dimensional (3D) brain organoids derived from human induced pluripotent stem cells (hiPSCs).

The working hypothesis is that 3D brain organoids can develop glioma-like structures and recapitulate phenotypic traits of gliomas when generated from hiPSCs expressing genetic mutants associated with glioma predisposition.

Methodology : To develop this pioneer study on the use of hiPSC-based brain organoids as a strategy to model gliomagenesis and study the impact of genetic mutants, it will be collect the peripheral blood mononuclear cell from 20 patients with high grade astrocytoma with or without IDH mutation. iPS will be generated from these PBMC and will be genetically modified according to different mutations. Then, it will be generate brain organoids according to standard protocols. Brain organoids generated from all different cells will be collected at different time points and analyzed for the presence of glioma-like structures and phenotypic hallmarks of gliomas.

From the proposed experiments, it will be expect that brain organoids will develop glioma-like features upon the presence of genetic mutations. Thus, it will be expect to demonstrate that brain organoids can be used as a reliable strategy to test the impact of genetic mutants, including the possible synergistic cooperation between different mutations on early gliomagenic events.


Condition or disease Intervention/treatment
Glioma Biological: Blood sample

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Organoids Derived From Induced-Pluripotent Stem Cells (iPS) From Patients
Estimated Study Start Date : June 7, 2019
Estimated Primary Completion Date : December 6, 2020
Estimated Study Completion Date : December 6, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patient with high grade astrocytoma
Patients meeting inclusion and non-inclusion criteria and having signed informed consent will be included in the study
Biological: Blood sample
A blood sample of two 10 mL ethylenediaminetetraacetic (EDTA) tubes will be taken at the time of the visit. This sample will be centrifuged for isolation of peripheral blood mononuclear cells (PBMC).




Primary Outcome Measures :
  1. Characterize the level of proliferation of organoids [ Time Frame: 18 months ]
    compare different immunohistochemical markings between organoids



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients managed for a brain tumor for whom a blood sample collected routinely will be recovered
Criteria

Inclusion Criteria:

  • Patient, male or female, aged 18 years or older
  • Astrocytoma grades 3 or 4, confirmed by anatomopathological diagnosis
  • Patient having signed an informed consent

Exclusion Criteria:

  • Person in emergency situation, a legal person of legal age (guardianship, guardianship or legal guardianship), or unable to express his / her consent
  • No affiliation to a social security scheme (beneficiary or beneficiary)
  • Pregnant or lactating woman

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): NCT03971812


Contacts
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Contact: Emeline TABOURET, PH 491385500 ext +33 emeline.tabouret@ap-hm.fr
Contact: Dominique FIGARELLA, PUPH 413429011 ext +33 dominique.figarella-branger@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Emeline TABOURET, PH    491385500 ext +33    emeline.tabouret@ap-hm.fr   
Principal Investigator: Emeline TABOURET         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03971812    
Other Study ID Numbers: 2019-01
2019-A00145-52 ( Other Identifier: ID RCB number )
RCAPHM19_0001 ( Other Identifier: AP-HM secondary number )
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No