Lung NeoplasmsNCT04159337
NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer
An observational study of Lung Neoplasms, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- The method of gene mutation detection
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2019to 31 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 in shanghai chest hospital
Who may be able to join
- Participant aged 18 or above, and gender unrestricted
- Individual with pathologically diagnosed lung cancer
Who cannot join
- Patients with concomitant other tumors
- Individual with severe cardiopulmonary insufficiency and hypoproteinemia
- Women who were pregnant and were during their lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Niu Xiaomin, ar_tey@hotmail.com
About this study
Official title: A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer
Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.
Read the detailed description
Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.
- Conditions
- Lung Neoplasms
- Being tested
- The method of gene mutation detection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The method of gene mutation detectionOther
All samples were detected by large-panel, whereas some of which were also detected by WES.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS refers to the time from initial treatment to the time of disease progression or death
Measured: through the whole study period, an average of 3 year
Tumor Mutational Burden (TMB)
TMB is defined as the total number of detected somatic mutation counts in coding regions per million bases
Measured: halfway of the study, an average of 1.5 year
Secondary outcomes (3)
Other biomarkers
The distribution and clinical application value of molecular biomarkers such as Neoantigen, MSI and LOH in Chinese lung cancer patients
Measured: halfway of the study, an average of 1.5 year
Clonality
The tumor clonality in Chinese lung cancer patients
Measured: halfway of the study, an average of 1.5 year
Overall survival (OS)
OS refers to the time from the patient entering into the group to the time of death
Measured: through the whole study period, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start30 Aug 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Shun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159337
- Sponsor's protocol ID
- ShanghaiChest0015
- Status last verified
- Nov 2019
- First submitted
- 23 Oct 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer
- ClinicalTrials.gov ID
- NCT04159337
- Acronym / sponsor ID
- ShanghaiChest0015
- Conditions
- Lung Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 12 Nov 2019 (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.
Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.
Detailed description
Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.
Study design
- Observational model
- Cohort
- 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 in shanghai chest hospital
Key inclusion criteria (2 listed)
- Participant aged 18 or above, and gender unrestricted
- Individual with pathologically diagnosed lung cancer
Key exclusion criteria (3 listed)
- Patients with concomitant other tumors
- Individual with severe cardiopulmonary insufficiency and hypoproteinemia
- Women who were pregnant and were during their lactation
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 |
|---|---|---|
| The method of gene mutation detectionAll samples were detected by large-panel, whereas some of which were also detected by WES. | Other | – |
Primary outcome
Progression-free survival (PFS)
Time frame: through the whole study period, an average of 3 year
PFS refers to the time from initial treatment to the time of disease progression or death
Tumor Mutational Burden (TMB)
Time frame: halfway of the study, an average of 1.5 year
TMB is defined as the total number of detected somatic mutation counts in coding regions per million bases
3 secondary outcomes
Other biomarkers
Time frame: halfway of the study, an average of 1.5 year
Clonality
Time frame: halfway of the study, an average of 1.5 year
Overall survival (OS)
Time frame: through the whole study period, an average of 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
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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.
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 Lung Neoplasms, 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 2 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: status not confirmed, as of the sponsor's last update on 12 Nov 2019. 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 Niu Xiaomin (021-22200000-3403, ar_tey@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: through the whole study period, an average of 3 year). The study lists 2 primary outcomes in all. 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 12 Nov 2019.