Adenocarcinoma of LungNCT04692935
Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis
An observational study of Adenocarcinoma of Lung, run by Jun Wang.
Trial summary
Lung adenocarcinomas (LUADs) from Asian ancestry are reported to have different genomic architectures compared with LUADs from Caucasian ancestry. However, due to lack of available cases, few studies controlled the clinical attributes during the comparisons of the genomic alterations. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adenocarcinoma of Lung
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital.
Who may be able to join
- Primary lung adenocarcinoma
- Broad-panel next-generation sequencing
- Asian
Who cannot join
- Inadequate clinicopathological information
- Low-quality next-generation sequencing
Trial locations and contacts
No sites are listed yet.
About this study
Lung adenocarcinomas (LUADs) from Asian ancestry are reported to have different genomic architectures compared with LUADs from Caucasian ancestry. However, due to lack of available cases, few studies controlled the clinical attributes during the comparisons of the genomic alterations. In this study, the investigators will identify Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital. Then, Caucasian LUADs patients who had targeted NGS (Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets [MSK-IMPACT]) will be identified in the GENIE database, which consists of 6673 primary lung adenocarcinoma samples with clinical annotations. Finally, genomic alterations regarding somatic mutations, copy number variations, fusions, mutational signatures, oncogenic pathways, and therapeutic actionability will be comprehensively compared between these two cohorts after adjusting age, sex, smoking status, and pathologic stage using propensity score matching. This study will elucidate important ancestry differences between Asian and Caucasian lung adenocarcinoma patients.
- Conditions
- Adenocarcinoma of Lung
- Keywords
- Lung adenocarcinoma, Next-generation sequencing, Tumor genomic profiling, Ethnic differences
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asian lung adenocarcinoma | Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital | |
| Caucasian lung adenocarcinoma | Caucasian LUADs patients who had targeted NGS (Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets [MSK-IMPACT]) will be identified in the AACR GENIE database, which consists of 6673 primary lung adenocarcinoma samples with clinical annotations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncoprint of somatic mutations
Association between genomic features and race
Measured: July 2021
Copy number variations (CNVs)
CNVs analysis by race
Measured: July 2021
Mutational signatures
Analysis of mutational signatures by race
Measured: August 2021
Oncogenic pathways
Analysis of oncogenic pathways by race
Measured: September 2021
Therapeutic actionability
Analysis of actionable alterations by race
Measured: October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of LungStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Berry Genomics Co., Ltd., Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor-investigator, Jun Wang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692935
- Sponsor's protocol ID
- 2020PHB375
- Status last verified
- Jan 2021
- First submitted
- 25 Dec 2020
- Last updated
- 5 Jan 2021
- 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 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis
- ClinicalTrials.gov ID
- NCT04692935
- Acronym / sponsor ID
- 2020PHB375
- Conditions
- Adenocarcinoma of Lung
- Keywords
- Lung adenocarcinoma, Next-generation sequencing, Tumor genomic profiling, Ethnic differences
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Jun WangUniversity, hospital or other
- Collaborators
- Berry Genomics Co., Ltd., Memorial Sloan Kettering Cancer Center
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Jan 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.
Lung adenocarcinomas (LUADs) from Asian ancestry are reported to have different genomic architectures compared with LUADs from Caucasian ancestry. However, due to lack of available cases, few studies controlled the clinical attributes during the comparisons of the genomic alterations. In this study, the investigators will identify Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital. Then, Caucasian LUADs patients who had targeted NGS (Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets [MSK-IMPACT]) will be identified in the GENIE database, which consists of 6673 primary lung adenocarcinoma samples with clinical annotations. Finally, genomic alterations regarding somatic mutations, copy number variations, fusions, mutational signatures, oncogenic pathways, and therapeutic actionability will be comprehensively compared between these two cohorts after adjusting age, sex, smoking status, and pathologic stage using propensity score matching. This study will elucidate important ancestry differences between Asian and Caucasian lung adenocarcinoma patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asian lung adenocarcinoma | – | –Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital |
| Caucasian lung adenocarcinoma | – | –Caucasian LUADs patients who had targeted NGS (Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets [MSK-IMPACT]) will be identified in the AACR GENIE database, which consists of 6673 primary lung adenocarcinoma samples with clinical annotations |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital.
Key inclusion criteria (3 listed)
- Primary lung adenocarcinoma
- Broad-panel next-generation sequencing
- Asian
Key exclusion criteria (2 listed)
- Inadequate clinicopathological information
- Low-quality next-generation sequencing
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
Oncoprint of somatic mutations
Time frame: July 2021
Association between genomic features and race
Copy number variations (CNVs)
Time frame: July 2021
CNVs analysis by race
Mutational signatures
Time frame: August 2021
Analysis of mutational signatures by race
Oncogenic pathways
Time frame: September 2021
Analysis of oncogenic pathways by race
Therapeutic actionability
Time frame: October 2021
Analysis of actionable alterations by race
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of Lung, run by Jun Wang.
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 3 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Jian Zhou, MD (010-88326650, zhoujianmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncoprint of somatic mutations (time frame: July 2021). The study lists 5 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 5 Jan 2021.