Glioma, MalignantNCT05100602
Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients
An observational study of Glioma, Malignant, run by Genetron Health at 4 sites in China.
Trial summary
The purpose of this trail is to evaluate the performance of Genetron TERT PCR Kit in Glioma patients using real-time PCR method. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma, Malignant
- How many people
- 1,192 participants
- Where
- 4 sitesChina
- Study dates
- 13 May 2016to 8 Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital sample
Who may be able to join
- Enroll cases in strict accordance with the requirements of the study
- The remaining samples after routine clinical testing
- The collection and processing of samples meet the requirements of standard laboratory operations and product instructions
- The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information
- Each sample must have HE staining results (hematoxylin-eosin staining)
- Pathological examination diagnosed as glioma, other brain tumors or normal tissues
- Number of samples: 10 pieces of each sample with a thickness of 10μm, and the tumor content is not less than 50%
Who cannot join
- The sample information is not complete
- Severely contaminated samples
- Samples that do not meet the requirements of sample collection and processing
Trial locations and contacts
4 sites in 1 country.
China4 sites
The First Hospital of Jilin University
Jilin City
Huashan Hospital of Fudan University
Shanghai
West China Hospital of Sichuan University
Sichuan
The Second Affiliated Hospital of Zhejiang University
Zhejiang
About this study
The purpose of this trail is to evaluate the performance of Genetron TERT PCR Kit in Glioma patients using real-time PCR method.
Read the detailed description
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with the Genetron TERT PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method.Combined with the results of clinicopathological classification, the incidence of C228T and C250T mutations of TERT promoter genes in different subtypes was counted to evaluate the clinical application performance of the Genetron TERT PCR Kit.
- Conditions
- Glioma, Malignant
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the Genetron TERT PCR Kit
The main purpose of this study is: by evaluating the Genetron TERT PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start13 May 2016
- Primary completion22 Sep 2016
- Study completion8 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genetron Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital, Zhejiang University, West China Hospital, The First Hospital of Jilin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100602
- Sponsor's protocol ID
- 2016063011442779
- Status last verified
- Jan 2017
- First submitted
- 20 Oct 2021
- Last updated
- 22 Nov 2021
- 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 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients
- ClinicalTrials.gov ID
- NCT05100602
- Acronym / sponsor ID
- 2016063011442779
- Conditions
- Glioma, Malignant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,192 participants (actual)
- Lead sponsor
- Genetron HealthIndustry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital, Zhejiang University, West China Hospital, The First Hospital of Jilin University
- Study start
- 13 May 2016 (actual)
- Primary completion
- 22 Sep 2016 (actual)
- Study completion
- 8 Dec 2016 (actual)
- First posted
- 29 Oct 2021 (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.
The purpose of this trail is to evaluate the performance of Genetron TERT PCR Kit in Glioma patients using real-time PCR method.
Detailed description
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with the Genetron TERT PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method.Combined with the results of clinicopathological classification, the incidence of C228T and C250T mutations of TERT promoter genes in different subtypes was counted to evaluate the clinical application performance of the Genetron TERT PCR Kit.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital sample
Key inclusion criteria (7 listed)
- Enroll cases in strict accordance with the requirements of the study
- The remaining samples after routine clinical testing
- The collection and processing of samples meet the requirements of standard laboratory operations and product instructions
- The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information
- Each sample must have HE staining results (hematoxylin-eosin staining)
Key exclusion criteria (3 listed)
- The sample information is not complete
- Severely contaminated samples
- Samples that do not meet the requirements of sample collection and processing
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
Efficacy of the Genetron TERT PCR Kit
Time frame: 3 months
The main purpose of this study is: by evaluating the Genetron TERT PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.
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 22 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, Malignant, run by Genetron Health at 4 sites in China.
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 7 inclusion and 3 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 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Efficacy of the Genetron TERT PCR Kit (time frame: 3 months). 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 22 Nov 2021.