Non-small Cell Lung CancerNCT03764917
NGS Combined With RNAseq on Tumor Immune Escape in NSCLC
An observational study of Non-small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Time
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy Without EGFR and Alk mutation
Who may be able to join
- Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy
Who cannot join
- EGFR mutant positive Alk mutant positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effect of NGS Combined With RNAseq on Tumor Immune Escape in Advanced Non-small Cell Lung Cancer EGFR and ALK Mutant Negative Patients
Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq
Read the detailed description
Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq. Detecting non-small cell lung cancer patient NGS and RNAseq data before first-line chemotherapy, after two cycles chemotherapy and after disease progression.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Time
- Keywords
- NGS, RNAseq
- 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.
TimeOther
Different detecting time
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of immune cells
detecting numbers of immune cells before first-line chemotherapy, after two cycles chemotherapy and after disease progression
Measured: 24 months
Secondary outcomes (1)
numbers of tumor mutations
detecting numbers of tumor mutations before first-line chemotherapy, after two cycles chemotherapy and after disease progression
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Dec 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Yayi He, MD, PHD, Principal investigator, Shanghai Pulmonary Hospital, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764917
- Sponsor's protocol ID
- YS2018-003
- Status last verified
- Mar 2020
- First submitted
- 3 Dec 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He Y, Chen L, Zhao L, Dang S, Liu G, Sasada S, Ma PC, van Zandwijk N, Rosell R, Popper HH, Wang H, Jiang M, Guo H, Liu X, Chen S, Zhang X, Xu M, Zhu B, Liu M, Zhou C. Genomic and transcriptional alterations in first-line chemotherapy exert a potentially unfavorable influence on subsequent immunotherapy in NSCLC. Theranostics. 2021 May 13;11(14):7092-7109. doi: 10.7150/thno.58039. eCollection 2021.
PubMed 34093873
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of NGS Combined With RNAseq on Tumor Immune Escape in Advanced Non-small Cell Lung Cancer EGFR and ALK Mutant Negative Patients
- ClinicalTrials.gov ID
- NCT03764917
- Acronym / sponsor ID
- YS2018-003
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NGS, RNAseq
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Dec 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.
Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq
Detailed description
Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq. Detecting non-small cell lung cancer patient NGS and RNAseq data before first-line chemotherapy, after two cycles chemotherapy and after disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy Without EGFR and Alk mutation
Key inclusion criteria (1 listed)
- Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy
Key exclusion criteria (1 listed)
- EGFR mutant positive Alk mutant positive
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 |
|---|---|---|
| TimeDifferent detecting time | Other | – |
Primary outcome
numbers of immune cells
Time frame: 24 months
detecting numbers of immune cells before first-line chemotherapy, after two cycles chemotherapy and after disease progression
1 secondary outcome
numbers of tumor mutations
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 34093873He Y, Chen L, Zhao L, Dang S, Liu G, Sasada S, Ma PC, van Zandwijk N, Rosell R, Popper HH, Wang H, Jiang M, Guo H, Liu X, Chen S, Zhang X, Xu M, Zhu B, Liu M, Zhou C. Genomic and transcriptional alterations in first-line chemotherapy exert a potentially unfavorable influence on subsequent immunotherapy in NSCLC. Theranostics. 2021 May 13;11(14):7092-7109. doi: 10.7150/thno.58039. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Yayi He, MD, PHD principal investigator
Shanghai Pulmonary Hospital, Tongji University
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 Non-small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China 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 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. 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?
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?
numbers of immune cells (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764917, which also lists 1 linked publication.
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 24 Mar 2020.