Preclinical Brain Tumor Models

Brain Metastases Clinical Trial

— HITCH  

Official title:

Establishment of Pre-clinical Stem Line and Tumoroid Models of Brain Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045065
• Other study ID #: RCAPHM20_0037 - HITCH
• Status: Recruiting
• Start date: January 2, 2022
• Est. completion date: January 2025

Study information

• Verified date: September 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Anaïs Maugard
• Phone: +33491435186
• Email: anais.maugard[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Primary or secondary brain tumors (metastases) remain associated with a very poor prognosis linked to significant therapeutic resistance. Thus, glioblastoma, which is the most common and aggressive primary brain tumor in adults, is associated with inevitable relapses within 7 to 10 months and median survival of approximately 12 to 14 months. At the same time, brain metastases are increasingly increasing following better systemic control of other metastatic sites and improvement in detection methods. However, they remain resistant to the latest therapeutic innovations such as immunotherapies or targeted therapies. In this context, innovative strategies are necessary to identify new therapeutic targets and implement new treatments to overcome resistance phenomena in the clinic. Objective: Our goal will be to generate tumoroids and stem-like cell lines (PDX) from patient tumor samples. Methods: We will establish tumor tumoroids and stem cell lines from patient samples. These preclinical models will allow us to test a large number of drugs, quickly and efficiently thanks to models as close as possible to patient tumors and limiting the use of animal models (3R). Overall, this project should enable major advances in the treatment of glioblastoma and brain metastases and enable the rapid testing of new molecules in clinical trials thanks to the homology of our models with our patients' diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients
• Brain tumor neuro-imaging
• Eligible for neurosurgery

Exclusion Criteria:

• unresectable tumor

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Other:
• Fresh tumor sampling
Patient samples will be collected during neurosurgical resection. .

Locations

Country	Name	City	State
France	Assistance publique hopitaux de marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumoroid and stem cell line generation	The generation of tumoroids and stem cell lines will be attested at 4 weeks after initiation of their culture.; Tumoroids: generation of round and viable structures Stem cell lines: generation of neurospheres	4 weeks after generation