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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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 101 studies in Carcinoma with a site in China — 37 open to participants now, 49 under way, 12 of them phase 3. Carcinoma · China.

Enrollment
13th of 19
100 · median 145
Started
2017
with 2 others
Observational
19 of 101
7 open now
Registered
31st of 101
by date
Lead sponsor
8 of 101
Peking University People's Hospital

Among the 101 studies in Carcinoma with a site in China, this one is the 13th largest by enrollment of the 19 observational ones, is one of 3 that started in 2017, is one of 19 observational ones, and was the 31st registered.

By phase

101 studies; the count open now beside each. This study's row is marked.

Phase 226 · 11 open
Phase 320 · 4 open
Observationalthis study19 · 7 open
Phase 112 · 6 open
No phase10 · 4 open
Phase 1/28 · 4 open
Phase 44 · 1 open
Phase 2/32 · 0 open

By the year they started

First in 2006; this study’s year is marked. 3 started in 2017.

Size and results

Median enrollment 72 across the 82 interventional studies, 145 across the 19 observational. Of the 29 that completed or were terminated, 13 (45%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 101 studies in Carcinoma with a site in China, or all of them as a file.
02

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.

03

Conditions studied

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

Keywords

  • Circulating Tumor DNA
  • Lung cancer Surgery
  • early diagnosis
  • immuno-sequencing
04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Sign 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

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

07

Study locations

1 site
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jul 2018, 9 months.

Of 50 non-industry observational studies under Carcinoma, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 114. This study's 9 months is below that.

Counting every sponsor, half of 62 studies reached it within 49 months; a quarter within 29 and three quarters within 166.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2017
First posted
Oct 24, 2017
StartActual
Oct 18, 2017
Primary completionActual
Jul 31, 2018
CompletionActual
Dec 31, 2018
Last update
Jan 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03320044
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.

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