Back to resultsEngineering Immune Organoids to Study Pediatric Cancer (IMMUNEORGANOID)
Primary Purpose
Brain Tumor, Kidney Tumor, Neuroblastoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Skin biopsy
Fresh tumor sample
Blood sample
Healthy tissue from the tumor
Spinal cerebrospinal fluid (SCF)
Sponsored by
About this trial
This is an interventional other trial for Brain Tumor
Eligibility Criteria
Inclusion Criteria: Age at diagnosis ≤ 25 years except for patients with malignant gliomas and renal tumors for whom no upper age limit is applied Medical suspicion or diagnosis of one of the following diseases, regardless of stage: Brain tumors Renal tumors Neuroblastoma Sarcomas Adult patient or parents or guardians should understand, sign and date the appropriate written informed consent from prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. Affiliated to a social security system or beneficiary of the same. Exclusion Criteria: Any histology not mentioned in the inclusion criteria Adult patient or parents/guardians incapable/incapable of giving its/their consent Patients deprived of their liberty by a judicial or administrative decision
Sites / Locations
- Gustave RoussyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Immune organoids from pediatric patient tissues using iPSC
Arm Description
To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
Outcomes
Primary Outcome Measures
Proportion of viable and exploitable immune organoids with engrafted tumor cells
Secondary Outcome Measures
Full Information
NCT ID
NCT05890781
First Posted
May 26, 2023
Last Updated
May 26, 2023
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT05890781
Brief Title
Engineering Immune Organoids to Study Pediatric Cancer
Acronym
IMMUNEORGANOID
Official Title
Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
May 2028 (Anticipated)
Study Completion Date
May 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Kidney Tumor, Neuroblastoma, Sarcoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immune organoids from pediatric patient tissues using iPSC
Arm Type
Other
Arm Description
To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)
Intervention Type
Procedure
Intervention Name(s)
Skin biopsy
Intervention Description
Skin biopsy
Intervention Type
Procedure
Intervention Name(s)
Fresh tumor sample
Intervention Description
Fresh tumor sample
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
Blood sample in heparin tubes (highly recommended), to be collected before starting treatment or as soon as hematological recovery has been reached
Intervention Type
Procedure
Intervention Name(s)
Healthy tissue from the tumor
Intervention Description
Healthy tissue from the tumor site whenever possible
Intervention Type
Procedure
Intervention Name(s)
Spinal cerebrospinal fluid (SCF)
Intervention Description
Spinal cerebrospinal fluid (SCF) whenever possible
Primary Outcome Measure Information:
Title
Proportion of viable and exploitable immune organoids with engrafted tumor cells
Time Frame
until 5 years after enrolment
10. Eligibility
Sex
All
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at diagnosis ≤ 25 years except for patients with malignant gliomas and renal tumors for whom no upper age limit is applied
Medical suspicion or diagnosis of one of the following diseases, regardless of stage:
Brain tumors
Renal tumors
Neuroblastoma
Sarcomas
Adult patient or parents or guardians should understand, sign and date the appropriate written informed consent from prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
Affiliated to a social security system or beneficiary of the same.
Exclusion Criteria:
Any histology not mentioned in the inclusion criteria
Adult patient or parents/guardians incapable/incapable of giving its/their consent
Patients deprived of their liberty by a judicial or administrative decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia PASQUALINI, MD
Phone
+33 (0)1 42 11 55 31
Email
claudia.pasqualini@gustaveroussy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jérémy MIONE, MS
Phone
+33 (0)1 42 11 42 11
Ext
38 61
Email
jeremy.mione@gustaveroussy.fr
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia PASQUALINI
Phone
+33 (0)1 42 11 55 31
Email
claudia.pasqualini@gustaveroussy.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Engineering Immune Organoids to Study Pediatric Cancer
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