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Preclinical Brain Tumor Models (HITCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045065
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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
Brain Metastases Diffuse Gliomas Other: Fresh tumor sampling

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Study Type : Observational
Estimated 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 : January 2, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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. .




Primary Outcome Measures :
  1. 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



Biospecimen Retention:   Samples Without DNA
fresh tumor sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with primitive tumor or with brain metastasis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unresectable tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045065


Contacts
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Contact: Anaïs Maugard +33491435186 anais.maugard@ap-hm.fr
Contact: APHM DRS promotion.interne@ap-hm.fr

Locations
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France
Assistance publique hopitaux de marseille Recruiting
Marseille, France
Contact: Emeline Tabouret         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT06045065    
Other Study ID Numbers: RCAPHM20_0037 - HITCH
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Brain metastases
Glioma
Glioblastoma
Preclinical models
Tumoroids
Cell lines
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases