Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients

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

UNKNOWN

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-31

Study Completion Date

2021-12-31

Brief Summary

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Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.

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Detailed Description

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Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients.

We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

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

* Aged 18 to 80 years
* Undergo radical surgery（R0 resection）
* Histologically confirmed diagnosis of stage ⅢA non-small cell lung cancer
* Positive Driver mutation(EGFR、PTEN、PIK3CA、BRAF、K-RAS、Her2) in tumor tissue
* Blood or urine circulating tumor detect the driver mutation detected in tumor tissue
* Patients must have given written informed consent

Exclusion Criteria

* Unable to comply with the study procedure
* Malignant tumor history within the past 5 years
* Patients who received any treatment prior to resection
* R1 or R2 resection
* Coexisting small cell lung cancer
* Received target drug therapy after surgery
* Unqualified blood or urine samples

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No