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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04692935
Other study ID # 2020PHB375
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2021
Est. completion date December 2021

Study information

Verified date January 2021
Source Peking University People's Hospital
Contact Jian Zhou, MD
Phone 010-88326650
Email zhoujianmd@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date December 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Primary lung adenocarcinoma - Broad-panel next-generation sequencing - Asian Exclusion Criteria: - Inadequate clinicopathological information - Low-quality next-generation sequencing

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Jun Wang Berry Genomics Co., Ltd., Memorial Sloan Kettering Cancer Center

Outcome

Type Measure Description Time frame Safety issue
Primary Oncoprint of somatic mutations Association between genomic features and race July 2021
Primary Copy number variations (CNVs) CNVs analysis by race July 2021
Primary Mutational signatures Analysis of mutational signatures by race August 2021
Primary Oncogenic pathways Analysis of oncogenic pathways by race September 2021
Primary Therapeutic actionability Analysis of actionable alterations by race October 2021
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