Non-Small Cell Lung CancerNCT05023746
Clinical Evaluation of Genetron Lung Cancer Panel in Non-small Cell Lung Cancer Patients
An observational study of Non-Small Cell Lung Cancer, run by Genetron Health at 4 sites in China.
Trial summary
The purpose of this trail is to evaluate the performance of Genetron lung cancer panel in non-small cell lung cancer patients using semiconductor sequencing method. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Genetron lung cancer panel
- How many people
- 1,052 participants
- Where
- 4 sitesChina
- Study dates
- 30 Aug 2018to 17 Sep 2019
- 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
- Cancer samClinically diagnosed as non-small cell lung samples (mainly lung adenocarcinoma and some lung squamous cell carcinoma, adenosquamous carcinoma, large cell carcinoma, etc.), and a small number of other cancer types are enrolled as interference samples.
- Collect some samples of relevant medical information before and after the use of targeted drugs. This part of the samples should have relevant previous molecular diagnosis results.
- Able to provide samples in time according to the requirements of the plan: samples for DNA/RNA extraction: 10 pieces of 10 µm thickness for each sample or 10 pieces of paraffin rolls. Samples for FISH experiment: 5 slices of 3-4µm thickness.
- The pathological examination conforms to the types of tissue samples listed in the above table. The HE staining results show that the tumor content is not less than 50%, and the paraffin slice damage should be avoided.
- The sample should have corresponding basic clinical information, including: patient visiting number/medical record number/specimen number, age, gender, pathological diagnosis result, molecular diagnosis result (if any).
Who cannot join
- Those who do not meet any of the above conditions are excluded. Reason: The included non-small cell lung adenocarcinoma samples and normal samples should have statistical significance, and the conclusions obtained should be scientific and valid. The selection of subjects for this study, while excluding research-related influencing factors, has no adverse effect on the health of the subjects.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
The First Hospital of Jilin University
Jilin City
The Second Affiliated Hospital Zhejiang University School of Medcine
Zhejiang
Henan Cancer Hospital
Zhengzhou
About this study
The purpose of this trail is to evaluate the performance of Genetron lung cancer panel in non-small cell lung cancer patients using semiconductor sequencing 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 Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The safety and effectiveness of this panel are confirmed and evaluated. Meanwhile, the accuracy of this panel for the following drug companion diagnostic tests: EGFR gene 19 exon deletion and L858R point mutation in gefitinib tablets, erlotinib hydrochloride and icotinib hydrochloride tablets, T790M point mutation in methanesulfonate acid osimertinib tablets, ALK gene fusion in crizotinib capsules.
The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Genetron lung cancer panel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetron lung cancer panelDiagnostic test
Follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.
| Study group | Role | What they receive |
|---|---|---|
| Clinically diagnosed as non-small cell lung cancer samples | Not described Receives: Diagnostic Test: Genetron lung cancer panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Genetron Lung Cancer Panel
The main purpose of this study is: by evaluating the Genetron Lung Cancer Panel to compare the results of simultaneous detection with similar products on the market and the Sanger sequencing method, and to calculate the coincidence rate and consistency of the panel and the comparison method.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start30 Aug 2018
- Primary completion9 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Retrospective
- Enrolment
- 1,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genetron Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Second Affiliated Hospital, Zhejiang University, School of Medicine, Henan Cancer Hospital, The First Hospital of Jilin University, Genetron Health (Beijing) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023746
- Sponsor's protocol ID
- 2019071915080046
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- 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 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Genetron Lung Cancer Panel in Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05023746
- Acronym / sponsor ID
- 2019071915080046
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,052 participants (actual)
- Lead sponsor
- Genetron HealthIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Second Affiliated Hospital, Zhejiang University, School of Medicine, Henan Cancer Hospital, The First Hospital of Jilin University, Genetron Health (Beijing) Co., Ltd.
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 27 Aug 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 lung cancer panel in non-small cell lung cancer patients using semiconductor sequencing method.
Detailed description
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The safety and effectiveness of this panel are confirmed and evaluated. Meanwhile, the accuracy of this panel for the following drug companion diagnostic tests: EGFR gene 19 exon deletion and L858R point mutation in gefitinib tablets, erlotinib hydrochloride and icotinib hydrochloride tablets, T790M point mutation in methanesulfonate acid osimertinib tablets, ALK gene fusion in crizotinib capsules.
The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinically diagnosed as non-small cell lung cancer samples | – | Diagnostic Test: Genetron lung cancer panel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital sample
Key inclusion criteria (5 listed)
- Cancer samClinically diagnosed as non-small cell lung samples (mainly lung adenocarcinoma and some lung squamous cell carcinoma, adenosquamous carcinoma, large cell carcinoma, etc.), and a small number of other cancer types are enrolled as interference samples.
- Collect some samples of relevant medical information before and after the use of targeted drugs. This part of the samples should have relevant previous molecular diagnosis results.
- Able to provide samples in time according to the requirements of the plan: samples for DNA/RNA extraction: 10 pieces of 10 µm thickness for each sample or 10 pieces of paraffin rolls. Samples for FISH experiment: 5 slices of 3-4µm thickness.
- The pathological examination conforms to the types of tissue samples listed in the above table. The HE staining results show that the tumor content is not less than 50%, and the paraffin slice damage should be avoided.
- The sample should have corresponding basic clinical information, including: patient visiting number/medical record number/specimen number, age, gender, pathological diagnosis result, molecular diagnosis result (if any).
Key exclusion criteria (1 listed)
- Those who do not meet any of the above conditions are excluded. Reason: The included non-small cell lung adenocarcinoma samples and normal samples should have statistical significance, and the conclusions obtained should be scientific and valid. The selection of subjects for this study, while excluding research-related influencing factors, has no adverse effect on the health of the subjects.
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 |
|---|---|---|
| Genetron lung cancer panelFollows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel. | Diagnostic test | Clinically diagnosed as non-small cell lung cancer samples |
Primary outcome
Efficacy of Genetron Lung Cancer Panel
Time frame: 2 months
The main purpose of this study is: by evaluating the Genetron Lung Cancer Panel to compare the results of simultaneous detection with similar products on the market and the Sanger sequencing method, and to calculate the coincidence rate and consistency of the panel and the comparison method.
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 1 Sep 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 Non-Small Cell Lung Cancer, 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 5 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 1 Sep 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 Genetron Lung Cancer Panel (time frame: 2 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 1 Sep 2021.