- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04692935
Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis
January 3, 2021 updated by: Jun Wang, Jun wang
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 Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Primary lung adenocarcinoma
- Broad-panel next-generation sequencing
- Asian
Exclusion Criteria:
- Inadequate clinicopathological information
- Low-quality next-generation sequencing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oncoprint of somatic mutations
Time Frame: July 2021
|
Association between genomic features and race
|
July 2021
|
|
Copy number variations (CNVs)
Time Frame: July 2021
|
CNVs analysis by race
|
July 2021
|
|
Mutational signatures
Time Frame: August 2021
|
Analysis of mutational signatures by race
|
August 2021
|
|
Oncogenic pathways
Time Frame: September 2021
|
Analysis of oncogenic pathways by race
|
September 2021
|
|
Therapeutic actionability
Time Frame: October 2021
|
Analysis of actionable alterations by race
|
October 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2021
Primary Completion (Anticipated)
July 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
December 25, 2020
First Submitted That Met QC Criteria
December 31, 2020
First Posted (Actual)
January 5, 2021
Study Record Updates
Last Update Posted (Actual)
January 5, 2021
Last Update Submitted That Met QC Criteria
January 3, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PHB375
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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