Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing
Genetic Variations,Immuno-sequencing and Circulating Tumor DNA(ctDNA) for Early Diagnosis of Small Pulmonary Nodules
1 other identifier
observational
100
1 country
1
Brief Summary
Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and evaluate peripheral blood detection for identifying nature of pulmonary nodule.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2017
CompletedFirst Submitted
Initial submission to the registry
October 20, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJanuary 9, 2019
January 1, 2019
10 months
October 20, 2017
January 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The sensitivity and specificity of combining peripheral plasma circulating tumor DNA and white cell immuno-sequencing in diagnosis of early stage non-small cell lung cancer
6 months
Secondary Outcomes (2)
The sensitivity and specificity of tissue immune repertoire in diagnosis of early stage non-small cell lung cancer
6 months
The concordance of peripheral plasma circulating tumor DNA and tumor tissue DNA in diagnosis of early stage non-small cell lung cancer
6 months
Eligibility Criteria
All patient are found small nodules in pulmonary and prepare for surgery
You may qualify if:
- Sign informed consent and consent to participate in this study;
- Found small nodules in pulmonary by CT and prepare for surgery;
You may not qualify if:
- Malignant tumor history within the past 5 years;
- Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
- Histology confirmed not non-small cell lung cancer
- No matching tissue or blood samplesUnqualified blood samples
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Related Publications (1)
Chen K, Bai J, Reuben A, Zhao H, Kang G, Zhang C, Qi Q, Xu Y, Hubert S, Chang L, Guan Y, Feng L, Zhang K, Zhang K, Yi X, Xia X, Cheng S, Yang F, Zhang J, Wang J. Multiomics Analysis Reveals Distinct Immunogenomic Features of Lung Cancer with Ground-Glass Opacity. Am J Respir Crit Care Med. 2021 Nov 15;204(10):1180-1192. doi: 10.1164/rccm.202101-0119OC.
PMID: 34473939DERIVED
Biospecimen
Blood sample from patient with small pulmonary nodule before surgery.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Wang, M.D.
Peking University People's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief，Thoracic Surgery Service
Study Record Dates
First Submitted
October 20, 2017
First Posted
October 24, 2017
Study Start
October 18, 2017
Primary Completion
July 31, 2018
Study Completion
December 31, 2018
Last Updated
January 9, 2019
Record last verified: 2019-01