免费获得国外相关药品，最快 1 个工作日回馈药物信息
Organoids Derived From Induced-Pluripotent Stem Cells (iPS) From Patients With High Grade Astrocytoma (GLIOMANOID)
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 |
| 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 |
| 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).
|
- Characterize the level of proliferation of organoids [ Time Frame: 18 months ]compare different immunohistochemical markings between organoids
| 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 |
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
| 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 |
| 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 | |
| Study Director: | Jean-Olivier ARNAUD, Director | Assistance Publique Hôpitaux de Marseille |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 31, 2019 | ||||
| First Posted Date | June 3, 2019 | ||||
| Last Update Posted Date | June 13, 2019 | ||||
| Estimated Study Start Date | June 7, 2019 | ||||
| Estimated Primary Completion Date | December 6, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Characterize the level of proliferation of organoids [ Time Frame: 18 months ] compare different immunohistochemical markings between organoids
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Organoids Derived From Induced-Pluripotent Stem Cells (iPS) From Patients With High Grade Astrocytoma | ||||
| Official Title | Organoids Derived From Induced-Pluripotent Stem Cells (iPS) From Patients | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients managed for a brain tumor for whom a blood sample collected routinely will be recovered | ||||
| Condition | Glioma | ||||
| Intervention | 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).
|
||||
| Study Groups/Cohorts | Patient with high grade astrocytoma
Patients meeting inclusion and non-inclusion criteria and having signed informed consent will be included in the study
Intervention: Biological: Blood sample
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
20 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 6, 2020 | ||||
| Estimated Primary Completion Date | December 6, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03971812 | ||||
| Other Study ID Numbers | 2019-01 2019-A00145-52 ( Other Identifier: ID RCB number ) RCAPHM19_0001 ( Other Identifier: AP-HM secondary number ) |
||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Assistance Publique Hopitaux De Marseille | ||||
| Study Sponsor | Assistance Publique Hopitaux De Marseille | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
||||
| PRS Account | Assistance Publique Hopitaux De Marseille | ||||
| Verification Date | June 2019 | ||||
