Preclinical Brain Tumor Models (HITCH)

September 13, 2023 updated by: Assistance Publique Hopitaux De Marseille

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Marseille, France
        • Recruiting
        • Assistance Publique Hopitaux de Marseille
        • Contact:
          • Emeline Tabouret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with primitive tumor or with brain metastasis

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • unresectable tumor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumoroid and stem cell line generation
Time Frame: 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
4 weeks after generation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAPHM20_0037 - HITCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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