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NCT05890781 Clinical Trial

Engineering Immune Organoids to Study Pediatric Cancer

Sarcoma Clinical Trial

— IMMUNEORGANOID  

Official title:
Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05890781
Other study ID # 2020-A03021-38
Secondary ID 2020/3712
Status Recruiting
Phase N/A
First received
Last updated
Start date May 12, 2023
Est. completion date May 2028

Study information
Verified date May 2023
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Claudia PASQUALINI, MD
Phone +33 (0)1 42 11 55 31
Email claudia.pasqualini@gustaveroussy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date May 2028
Est. primary completion date May 2028
Accepts healthy volunteers No
Gender All
Age group N/A to 25 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Skin biopsy
Skin biopsy
• Fresh tumor sample
Fresh tumor sample
Biological:
• Blood sample
Blood sample in heparin tubes (highly recommended), to be collected before starting treatment or as soon as hematological recovery has been reached
Procedure:
• Healthy tissue from the tumor
Healthy tissue from the tumor site whenever possible
• Spinal cerebrospinal fluid (SCF)
Spinal cerebrospinal fluid (SCF) whenever possible

Locations
Country Name City State
France Gustave Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of viable and exploitable immune organoids with engrafted tumor cells until 5 years after enrolment
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