Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis

Sponsor

Jun Wang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04692935

Collaborator

Berry Genomics Co., Ltd. (Industry), Memorial Sloan Kettering Cancer Center (Other)

450

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of Lung

Study Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Oncoprint of somatic mutations [July 2021]
Association between genomic features and race
Copy number variations (CNVs) [July 2021]
CNVs analysis by race
Mutational signatures [August 2021]
Analysis of mutational signatures by race
Oncogenic pathways [September 2021]
Analysis of oncogenic pathways by race
Therapeutic actionability [October 2021]
Analysis of actionable alterations by race

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary lung adenocarcinoma
Broad-panel next-generation sequencing
Asian

Exclusion Criteria:

Inadequate clinicopathological information
Low-quality next-generation sequencing

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jun Wang, Professor, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT04692935

Other Study ID Numbers:

2020PHB375

First Posted:

Jan 5, 2021

Last Update Posted:

Jan 5, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jun Wang, Professor, Peking University People's Hospital

Lung adenocarcinoma

Next-generation sequencing

Tumor genomic profiling

Ethnic differences

Additional relevant MeSH terms:

Adenocarcinoma

Adenocarcinoma of Lung

Study Results

No Results Posted as of Jan 5, 2021