NCT04692935

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

December 25, 2020

Last Update Submit

January 3, 2021

Conditions

Adenocarcinoma of Lung

Keywords

Lung adenocarcinomaNext-generation sequencingTumor genomic profilingEthnic differences

Outcome Measures

Primary Outcomes (5)

  • Oncoprint of somatic mutations

    Association between genomic features and race

    July 2021

  • Copy number variations (CNVs)

    CNVs analysis by race

    July 2021

  • Mutational signatures

    Analysis of mutational signatures by race

    August 2021

  • Oncogenic pathways

    Analysis of oncogenic pathways by race

    September 2021

  • Therapeutic actionability

    Analysis of actionable alterations by race

    October 2021

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Primary lung adenocarcinoma
  • Broad-panel next-generation sequencing
  • Asian

You may not qualify if:

  • Inadequate clinicopathological information
  • Low-quality next-generation sequencing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Central Study Contacts

Jian Zhou, MD

CONTACT

010-88326650zhoujianmd@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 25, 2020

First Posted

January 5, 2021

Study Start

January 1, 2021

Primary Completion

July 1, 2021

Study Completion

December 1, 2021

Last Updated

January 5, 2021

Record last verified: 2021-01