Malignant GliomaNCT05486247
Molecular Characterization of Gliomas Using a Broad Next Generation Sequencing (NGS)Panel
An observational study of Malignant Glioma, run by Hellenic Cooperative Oncology Group.
Trial summary
Gliomas are the most common malignant primary brain tumors with poor prognosis. The genotyping of tumors using NGS platforms enables the identification of genetic alterations that constitute diagnostic, prognostic and predictive biomarkers.Here in, we investigated the molecular profile of 32 tumor samples from 32… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2015to 1 May 2022
- 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 diagnosis of high grade glioma treated in 2 centers of the Hellenic Cooperative Oncology Group (HeCOG).
Who may be able to join
- Diagnosis of high grade glioma based on tissue biopsy
Who cannot join
None listed.
About this study
Official title: Molecular Characterization of Gliomas Using a Broad NGS Panel
Gliomas are the most common malignant primary brain tumors with poor prognosis. The genotyping of tumors using NGS platforms enables the identification of genetic alterations that constitute diagnostic, prognostic and predictive biomarkers.Here in, we investigated the molecular profile of 32 tumor samples from 32 patients with high grade gliomas by implementing a broad 80-gene targeted NGS panel while reporting their clinicopathological characteristics and outcomes.
- Conditions
- Malignant Glioma
- Keywords
- Molecular profile, Mutational status
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of genetic alterations in patients with high grade glioma using a 80 gene NGS panel
The prevalence of genetic alterations in patients with high grade glioma using a 80 gene NGS panel
Measured: April 2019 - December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start4 Feb 2015
- Primary completion1 Dec 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Romanidou, Hellenic Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486247
- Sponsor's protocol ID
- NGSGLIOMA
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 3 Aug 2022
- 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 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Gliomas Using a Broad NGS Panel
- ClinicalTrials.gov ID
- NCT05486247
- Acronym / sponsor ID
- NGSGLIOMA
- Conditions
- Malignant Glioma
- Keywords
- Molecular profile, Mutational status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 4 Feb 2015 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 3 Aug 2022 (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.
Gliomas are the most common malignant primary brain tumors with poor prognosis. The genotyping of tumors using NGS platforms enables the identification of genetic alterations that constitute diagnostic, prognostic and predictive biomarkers.Here in, we investigated the molecular profile of 32 tumor samples from 32 patients with high grade gliomas by implementing a broad 80-gene targeted NGS panel while reporting their clinicopathological characteristics and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of high grade glioma treated in 2 centers of the Hellenic Cooperative Oncology Group (HeCOG).
Key inclusion criteria (1 listed)
- Diagnosis of high grade glioma based on tissue biopsy
Key exclusion criteria (0 listed)
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
The prevalence of genetic alterations in patients with high grade glioma using a 80 gene NGS panel
Time frame: April 2019 - December 2021
The prevalence of genetic alterations in patients with high grade glioma using a 80 gene NGS panel
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 3 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Glioma, run by Hellenic Cooperative Oncology Group.
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 1 inclusion and 0 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The prevalence of genetic alterations in patients with high grade glioma using a 80 gene NGS panel (time frame: April 2019 - December 2021). 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 3 Aug 2022.