CClinicalTrials.gg
Sign In
CompletedNCT03320044Updated Jan 9, 2019

Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing

An observational study in Carcinoma, Non-small-cell Lung Cancer and Lung Neoplasm, sponsored by Peking University People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Peking University People's Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

Analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and evaluate peripheral blood detection for identifying nature of pulmonary nodule.

Read the detailed description

Early diagnosis of lung cancer is of vital importance in lung cancer treatment. This research will first analyse the features of immune repertoire and genetic mutations from tissue of benign and malignant pulmonary nodule，then explore the feasibility of detecting these features from peripheral blood sample, and finally evaluate peripheral blood detection of lung cancer related immune repertoire and genetic mutations for identifying nature of pulmonary nodule.

02

Conditions studied

  • Carcinoma
  • Non-small-cell Lung Cancer
  • Lung Neoplasm

Keywords

  • Circulating Tumor DNA
  • Lung cancer Surgery
  • early diagnosis
  • immuno-sequencing
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patient are found small nodules in pulmonary and prepare for surgery

Inclusion criteria

  1. Sign informed consent and consent to participate in this study;
  2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion criteria

Exclusion Criteria:

  1. Malignant tumor history within the past 5 years;
  2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
  3. Histology confirmed not non-small cell lung cancer
  4. No matching tissue or blood samplesUnqualified blood samples
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. The sensitivity and specificity of tissue immune repertoire in diagnosis of early stage non-small cell lung cancer

    Time frame: 6 months

  2. The concordance of peripheral plasma circulating tumor DNA and tumor tissue DNA in diagnosis of early stage non-small cell lung cancer

    Time frame: 6 months

06

Study locations

1 site
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
07

References and documents

Publications

  • 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. PubMed 34473939 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03320044
Lead sponsor
Peking University People's Hospital
Responsible party
Jun Wang (Chief，Thoracic Surgery Service, Peking University People's Hospital) — Principal investigator
First posted
Oct 24, 2017
Start date
Oct 18, 2017
Primary completion
Jul 31, 2018
Completion
Dec 31, 2018
Last update
Jan 9, 2019

Study contacts

Jun Wang, M.D.
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Neoplasms→

Other studies from this sponsor

Peking University People's Hospital

Start the discussion