MeningiomaNCT04478877
Establishment and Characterization of Meningioma Patient-derived Organoids
An observational study of Meningioma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
In this study, meningioma organoids will be established from patients' tissues and the characterization of the organoid will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 May 2020to 31 Aug 2023
- 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 meningioma admitted to Prince Wales Hospitals neurosurgical services
Who may be able to join
- Adult patients (aged >18 years) with meningioma
- Admission into Prince Wales hospitals neurosurgical services
- Patients with surgical needs of meningioma removal
Who cannot join
- 1. Patients (or next-of-kin as appropriate) refuse to participate into the study
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Surgery, The Chinese University of Hong Kong
Hong Kong
About this study
In this study, meningioma organoids will be established from patients' tissues and the characterization of the organoid will be performed.
Read the detailed description
Aims and Hypothesis to be tested:
The investigators hypothesized that the derived organoid should have a similar morphological and genetic mutation signatures to the patient primary tissue.
Study period: 1 year for patient recruitment and organoid generation from patient tumor
Study population: 30
Study samples:
Patient's meningioma tumor sample are collected from patients with surgical needs. Sample collected are used for organoid culture. Morphological and genetic characteristics will be compared between the patient tumor sample and the corresponding derived organoids
Primary outcome measures:
Whole exome sequencing data of patient tumor tissue and patients-derived organoids
- Conditions
- Meningioma
- Medical subject headings
- Meningioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole exome sequencing data
DNA extracted from patient tumor tissue and patients-derived organoids will be perform whole exome sequencing for genetic characterization.
Measured: 7 days
Secondary outcomes (1)
Immunostaining
H\&E staining and meningioma markers immunostaining
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start23 May 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George KC Wong, Chinese University of Hong Kong
- Investigators
- George KC Wong, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478877
- Sponsor's protocol ID
- GWMO01
- Status last verified
- Sep 2023
- First submitted
- 16 Jul 2020
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Characterization of Meningioma Patient-derived Organoids
- ClinicalTrials.gov ID
- NCT04478877
- Acronym / sponsor ID
- GWMO01
- Conditions
- Meningioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 23 May 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 21 Jul 2020 (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.
In this study, meningioma organoids will be established from patients' tissues and the characterization of the organoid will be performed.
Detailed description
Aims and Hypothesis to be tested:
The investigators hypothesized that the derived organoid should have a similar morphological and genetic mutation signatures to the patient primary tissue.
Study period: 1 year for patient recruitment and organoid generation from patient tumor
Study population: 30
Study samples:
Patient's meningioma tumor sample are collected from patients with surgical needs. Sample collected are used for organoid culture. Morphological and genetic characteristics will be compared between the patient tumor sample and the corresponding derived organoids
Primary outcome measures:
Whole exome sequencing data of patient tumor tissue and patients-derived organoids
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with meningioma admitted to Prince Wales Hospitals neurosurgical services
Key inclusion criteria (3 listed)
- Adult patients (aged >18 years) with meningioma
- Admission into Prince Wales hospitals neurosurgical services
- Patients with surgical needs of meningioma removal
Key exclusion criteria (1 listed)
- 1. Patients (or next-of-kin as appropriate) refuse to participate into the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whole exome sequencing data
Time frame: 7 days
DNA extracted from patient tumor tissue and patients-derived organoids will be perform whole exome sequencing for genetic characterization.
1 secondary outcome
Immunostaining
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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.
George KC Wong principal investigator
Chinese University of Hong Kong
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 Meningioma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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: finished, as of the sponsor's last update on 7 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole exome sequencing data (time frame: 7 days). 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 7 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.