Malignant HydrothoraxNCT03546452
A Prospective Study to Evaluate the Consistency of Next-Generation Sequencing(NGS)-Panels by Using Malignant Hydrothorax Form NSCLC
An observational study of Malignant Hydrothorax and NSCLC, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
A prospective study to evaluate consistency of different NGS-panel. Cell free DNA is purified from each malignant hydrothorax from NSCLC .Different NGS-panels are applied to perform in vitro diagnosis to detect Single Nucleotide Variants(SNV) and to calculate TMB value in these DNA samples.Consistency of enrolled… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Hydrothorax, NSCLC
- What is being tested?
- in vitro NGS-panel
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2018to 1 May 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: patients in shanghai chest hospital
Who may be able to join
- Advanced malignant lung cancer, with treatment of pleural effusion, hydrothorax volume not less than 800ml
Who cannot join
- The sample size is not sufficient to detect.
- There are not enough tumor cells in the tissue section to be evaluated through the pathology department of the chest Hospital.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shangha Chest Hospital
Shanghai, Shanghai Municipality, 200030
yongfeng yu, 18017321559, yuyongfeng212@126.com
About this study
Official title: A Prospective Study to Evaluate the Results of Different NGS- Panels in Mutation Detection and Tumor Mutation Burden(TMB) Calculation by Using Malignant Hydrothorax From NSCLC
A prospective study to evaluate consistency of different NGS-panel. Cell free DNA is purified from each malignant hydrothorax from NSCLC .Different NGS-panels are applied to perform in vitro diagnosis to detect Single Nucleotide Variants(SNV) and to calculate TMB value in these DNA samples.Consistency of enrolled NGS-panels are then evaluated by statistical analysis.
Read the detailed description
- Chest Hospital in accordance with the clinical requirements of the treatment required to extract ML hydrothorax sent to hospital pathology department for exfoliated Cell diagnosis and production of cell wax block, while the additional responsibility for the extraction of hydrothorax 500ml, and collect 10ml venous blood sample, Venous blood samples are stored in either the A cell-free DNA Blood collection Tube (STRECK tube) or the ethylenediaminetetraacetic acid(EDTA) anticoagulant tube.
- Amoy Diagnostics Co., Ltd. (AmoyDx) is responsible for plasma separation after sampling 2 hours, plasma is frozen by the chest Hospital, AmoyDx completes the purification of peripheral blood cells genomic DNA , and which is divided into 6 parts ,5 of which are send to in vitro diagnostic products (IVD) enterprises to perform NGS-Panel detection.
- 100ml hydrothorax is send to each IVD enterprise.
- Each IVD enterprise carries on the hydrothorax cell free DNA and peripheral blood cell genomic DNA NGS-Panel detection according to their own protocol.
- Each IVD enterprise will complete the test within 7-10 working days and fill out the results in accordance with the report template provided by this research project (provided by Guangzhou Burning Rock Medical Examination Institute Co., Ltd.) and submit to sponsor by email.
- Sponsor would use whole exon panel (WES) to obtain an TMB value if needed.
- Employ four-grid analysis to evaluate positive compliance rate, negative compliance rate, total compliance rate of all submitted data.
- Employ kappa test to evaluate the consistency of each two detections.
- Conditions
- Malignant Hydrothorax, NSCLC
- Being tested
- in vitro NGS-panel
- Keywords
- NSCLC, malignant hydrothorax, prospective study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vitro NGS-panelDiagnostic test
cell free DNA ,which was purified from hydrothorax, is used to be tested by NGS-panel
| Study group | Role | What they receive |
|---|---|---|
| malignant NSCLC hydrothorax | cell free DNA ,which is purified from malignant NSCLC hydrothorax, tested by in vitro NGS-panel Receives: Diagnostic Test: in vitro NGS-panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate consistency of TMB value of different NGS-Panel
All DNA samples were tested to calculate TMB value by all enrolled NGS-panel (include WES if necessary), each sample is then to be marked as TMB high, TMB median or TMB low according to the cutoff value identified by different IVD enterprises.
Employ Cohen's kappa test to calculate the kappa value to measures inter-rater agreement for categorical result.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start18 May 2018
- Primary completion30 Sep 2018 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant HydrothoraxStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sinotech Genomics Co., Ltd, Amoy Diagnostics, Guangzhou Burning Rock Medical Examination Institute Co., Ltd., Geneplus-Beijing Co. Ltd., Berry Genomics Co., Ltd.
- Responsible party
- Principal investigator, Lu Shun, Shanghai Chest Hospital
- Investigators
- shun lu, Prof., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546452
- Sponsor's protocol ID
- shanghai Chest 0014
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Results of Different NGS- Panels in Mutation Detection and Tumor Mutation Burden(TMB) Calculation by Using Malignant Hydrothorax From NSCLC
- ClinicalTrials.gov ID
- NCT03546452
- Acronym / sponsor ID
- shanghai Chest 0014
- Conditions
- Malignant Hydrothorax, NSCLC
- Keywords
- NSCLC, malignant hydrothorax, prospective study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Sinotech Genomics Co., Ltd, Amoy Diagnostics, Guangzhou Burning Rock Medical Examination Institute Co., Ltd., Geneplus-Beijing Co. Ltd., Berry Genomics Co., Ltd.
- Study start
- 18 May 2018 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 6 Jun 2018 (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.
A prospective study to evaluate consistency of different NGS-panel. Cell free DNA is purified from each malignant hydrothorax from NSCLC .Different NGS-panels are applied to perform in vitro diagnosis to detect Single Nucleotide Variants(SNV) and to calculate TMB value in these DNA samples.Consistency of enrolled NGS-panels are then evaluated by statistical analysis.
Detailed description
- Chest Hospital in accordance with the clinical requirements of the treatment required to extract ML hydrothorax sent to hospital pathology department for exfoliated Cell diagnosis and production of cell wax block, while the additional responsibility for the extraction of hydrothorax 500ml, and collect 10ml venous blood sample, Venous blood samples are stored in either the A cell-free DNA Blood collection Tube (STRECK tube) or the ethylenediaminetetraacetic acid(EDTA) anticoagulant tube.
- Amoy Diagnostics Co., Ltd. (AmoyDx) is responsible for plasma separation after sampling 2 hours, plasma is frozen by the chest Hospital, AmoyDx completes the purification of peripheral blood cells genomic DNA , and which is divided into 6 parts ,5 of which are send to in vitro diagnostic products (IVD) enterprises to perform NGS-Panel detection.
- 100ml hydrothorax is send to each IVD enterprise.
- Each IVD enterprise carries on the hydrothorax cell free DNA and peripheral blood cell genomic DNA NGS-Panel detection according to their own protocol.
- Each IVD enterprise will complete the test within 7-10 working days and fill out the results in accordance with the report template provided by this research project (provided by Guangzhou Burning Rock Medical Examination Institute Co., Ltd.) and submit to sponsor by email.
- Sponsor would use whole exon panel (WES) to obtain an TMB value if needed.
- Employ four-grid analysis to evaluate positive compliance rate, negative compliance rate, total compliance rate of all submitted data.
- Employ kappa test to evaluate the consistency of each two detections.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| malignant NSCLC hydrothorax | – | Diagnostic Test: in vitro NGS-panelcell free DNA ,which is purified from malignant NSCLC hydrothorax, tested by in vitro NGS-panel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients in shanghai chest hospital
Key inclusion criteria (1 listed)
- Advanced malignant lung cancer, with treatment of pleural effusion, hydrothorax volume not less than 800ml
Key exclusion criteria (2 listed)
- The sample size is not sufficient to detect.
- There are not enough tumor cells in the tissue section to be evaluated through the pathology department of the chest Hospital.
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 |
|---|---|---|
| in vitro NGS-panelcell free DNA ,which was purified from hydrothorax, is used to be tested by NGS-panel | Diagnostic test | malignant NSCLC hydrothorax |
Primary outcome
Evaluate consistency of TMB value of different NGS-Panel
Time frame: 5 months
All DNA samples were tested to calculate TMB value by all enrolled NGS-panel (include WES if necessary), each sample is then to be marked as TMB high, TMB median or TMB low according to the cutoff value identified by different IVD enterprises. Employ Cohen's kappa test to calculate the kappa value to measures inter-rater agreement for categorical result.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Malignant Hydrothorax
RecruitingObservational study
Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing
Lung Cancer, Breast Cancer
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.
shun lu, Prof. principal investigator
Shanghai Chest Hospital
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 Malignant Hydrothorax and NSCLC, run by Shanghai Chest Hospital at 1 site 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 1 inclusion and 2 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 7 Jun 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shun lu, Prof. (021-2220000, shun_lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate consistency of TMB value of different NGS-Panel (time frame: 5 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 7 Jun 2018.