HITCH: Preclinical Brain Tumor Models

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Recruiting
CT.gov ID
NCT06045065
Collaborator
(none)
60
1
36
1.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fresh tumor sampling

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Establishment of Pre-clinical Stem Line and Tumoroid Models of Brain Tumors
Actual Study Start Date :
Jan 2, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
patients with primitive tumor

Patient samples will be collected during routine care neurosurgical resection.

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

patients with brain metastasis

Patient samples will be collected during routine care neurosurgical resection.

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

Outcome Measures

Primary Outcome Measures

  1. Tumoroid and stem cell line generation [4 weeks after 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients

  • Brain tumor neuro-imaging

  • Eligible for neurosurgery

Exclusion Criteria:
  • unresectable tumor

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance publique hopitaux de marseille Marseille France

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT06045065
Other Study ID Numbers:
  • RCAPHM20_0037 - HITCH
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique Hopitaux De Marseille
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023