Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

NCT ID: NCT02965391

Last Updated: 2020-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma Non-small-cell Lung Cancer Lung Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen KeZhong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Wang, M.D.

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 31439586 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29437753 (View on PubMed)

Other Identifiers

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PTHO1602

Identifier Type: -

Identifier Source: org_study_id

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