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CompletedNCT02965391Updated Mar 27, 2020

Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

An observational study in Carcinoma, Non-small-cell Lung Cancer and Lung Neoplasms, 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 2020-03-27.

Sponsored by Peking University People's Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

Read the detailed description

For lung cancer patients who received surgery, multiple time of plasma will be collected before or after surgery. A series of mutations will be detected in plasma before surgery based on next generation sequencing. The positive mutation will be traced after surgery and in follow up.

02

Conditions studied

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

Keywords

  • Circulating Tumor DNA
  • Half time
  • Lung cancer
  • Surgery
  • Surveillance
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 20 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Histologically confirmed lung cancer patients who received completely tumor resection

Inclusion criteria

  • Suspected lung cancer before surgery
  • No malignant tumor history within the past 5 years
  • The pulmonary nodule is not pure ground glass opacity
  • Patients must have given written informed consent

Exclusion criteria

Exclusion Criteria:

  • Multiple primary lung cancer
  • R1,R2 resection
  • Histology confirmed not non-small cell lung cancer
  • Unqualified blood samples
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (actual)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Half-life of circulating tumor DNA after surgery

    Time frame: 3 months

Secondary outcomes

  1. The variation of circulating tumor DNA level before and after surgery

    Time frame: 3 months

  2. Correlation of circulating tumor DNA level after surgery with tumor recurrence

    Time frame: 3 years

  3. Correlation of circulating tumor DNA level after surgery with clinical features

    Time frame: 3 months

07

Study locations

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

References and documents

Publications

  • Chen K, Zhao H, Shi Y, Yang F, Wang LT, Kang G, Nie Y, Wang J. Perioperative Dynamic Changes in Circulating Tumor DNA in Patients with Lung Cancer (DYNAMIC). Clin Cancer Res. 2019 Dec 1;25(23):7058-7067. doi: 10.1158/1078-0432.CCR-19-1213. Epub 2019 Aug 22. PubMed 31439586 ↗
  • Chen K, Zhao H, Yang F, Hui B, Wang T, Wang LT, Shi Y, Wang J. Dynamic changes of circulating tumour DNA in surgical lung cancer patients: protocol for a prospective observational study. BMJ Open. 2018 Feb 6;8(2):e019012. doi: 10.1136/bmjopen-2017-019012. PubMed 29437753 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02965391
Lead sponsor
Peking University People's Hospital
Collaborators
National Natural Science Foundation of China
Responsible party
Chen KeZhong (Principal Investigator, Peking University People's Hospital) — Principal investigator
First posted
Nov 16, 2016
Start date
Nov 2016
Primary completion
Sep 2017
Completion
Nov 2019
Last update
Mar 27, 2020

Study contacts

Jun Wang, M.D.
study chair · Peking University People's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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