Brain MetastasesHITCHNCT06045065
Preclinical Brain Tumor Models
An observational study of Brain Metastases and Diffuse Gliomas, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Diffuse Gliomas
- What is being tested?
- Fresh tumor sampling
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2022to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with primitive tumor or with brain metastasis
Who may be able to join
- Adult patients
- Brain tumor neuro-imaging
- Eligible for neurosurgery
Who cannot join
- unresectable tumor
Trial locations and contacts
1 site in 1 country.
APHM DRS contact
France1 site, 1 recruiting
- Recruiting
Assistance publique hopitaux de marseille
Marseille
Emeline Tabouret
About this study
Official title: 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.
Read more
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.
- Conditions
- Brain Metastases, Diffuse Gliomas
- Being tested
- Fresh tumor sampling
- Keywords
- Brain metastases, Glioma, Glioblastoma, Preclinical models, Tumoroids, Cell lines
- Medical subject headings
- Brain Neoplasms, Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh tumor samplingOther
Patient samples will be collected during neurosurgical resection. .
| Study group | Role | What they receive |
|---|---|---|
| patients with primitive tumor | Patient samples will be collected during routine care neurosurgical resection. Receives: Other: Fresh tumor sampling | |
| patients with brain metastasis | Patient samples will be collected during routine care neurosurgical resection. Receives: Other: Fresh tumor sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks after generation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 Jan 2022
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045065
- Sponsor's protocol ID
- RCAPHM20_0037 - HITCH
- Acronym
- HITCH
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Pre-clinical Stem Line and Tumoroid Models of Brain Tumors
- ClinicalTrials.gov ID
- NCT06045065
- Acronym / sponsor ID
- HITCH / RCAPHM20_0037 - HITCH
- Conditions
- Brain Metastases, Diffuse Gliomas
- Keywords
- Brain metastases, Glioma, Glioblastoma, Preclinical models, Tumoroids, Cell lines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with primitive tumor | – | Other: Fresh tumor samplingPatient samples will be collected during routine care neurosurgical resection. |
| patients with brain metastasis | – | Other: Fresh tumor samplingPatient samples will be collected during routine care neurosurgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with primitive tumor or with brain metastasis
Key inclusion criteria (3 listed)
- Adult patients
- Brain tumor neuro-imaging
- Eligible for neurosurgery
Key exclusion criteria (1 listed)
- unresectable tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh tumor samplingPatient samples will be collected during neurosurgical resection. . | Other | patients with brain metastasis, patients with primitive tumor |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
APHM DRS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases and Diffuse Gliomas, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anaïs Maugard (+33491435186, anais.maugard@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumoroid and stem cell line generation (time frame: 4 weeks after generation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 27 Oct 2026.