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OpenTrials
Completed

NCT Number: NCT02965391

Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

Dynamic Changes and Surveillance of Circulating Tumor DNA in Surgical Non-small Cell Lung Cancer Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Nov 16, 2016
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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