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Trial Title:
Engineering Immune Organoids to Study Pediatric Cancer
NCT ID:
NCT05890781
Condition:
Brain Tumor
Kidney Tumor
Neuroblastoma
Sarcoma
Conditions: Official terms:
Neuroblastoma
Kidney Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Skin biopsy
Description:
Skin biopsy
Arm group label:
Immune organoids from pediatric patient tissues using iPSC
Intervention type:
Procedure
Intervention name:
Fresh tumor sample
Description:
Fresh tumor sample
Arm group label:
Immune organoids from pediatric patient tissues using iPSC
Intervention type:
Biological
Intervention name:
Blood sample
Description:
Blood sample in heparin tubes (highly recommended), to be collected before starting
treatment or as soon as hematological recovery has been reached
Arm group label:
Immune organoids from pediatric patient tissues using iPSC
Intervention type:
Procedure
Intervention name:
Healthy tissue from the tumor
Description:
Healthy tissue from the tumor site whenever possible
Arm group label:
Immune organoids from pediatric patient tissues using iPSC
Intervention type:
Procedure
Intervention name:
Spinal cerebrospinal fluid (SCF)
Description:
Spinal cerebrospinal fluid (SCF) whenever possible
Arm group label:
Immune organoids from pediatric patient tissues using iPSC
Summary:
To engineer immune organoids from pediatric patient tissues using induced-pluripotent
stem cells (iPSC)
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Claudia PASQUALINI
Phone:
+33 (0)1 42 11 55 31
Email:
claudia.pasqualini@gustaveroussy.fr
Start date:
May 12, 2023
Completion date:
May 2028
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05890781
