Circulating Tumor DNA in Surgical Lung Cancer Patients

NCT ID: NCT03081741

Last Updated: 2017-05-23

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-03

Study Completion Date

2020-03-18

Brief Summary

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Conduct a prospective study to detect the change of ctDNA of surgical lung cancer patients.

Detailed Description

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Studies have shown the feasibility of detecting mutation status by blood circulating tumor DNA (ctDNA) in lung cancer patients.

The investigators plan to test the blood ctDNA in surveillance of surgical lung cancer patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Conditions

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Lung Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Aged 18 to 80 years Undergo radical surgery Histologically confirmed diagnosis of lung cancer Considered primary lung cancer by clinical criteria Patients must have given written informed consent

Exclusion Criteria

Unable to comply with the study procedure Malignant tumor history Patients who received any treatment prior to resection Unqualified blood samples
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

Shenzhen Gene Health Bio Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geng Tian, MD

Role: STUDY_CHAIR

Shenzhen Second People's Hospital

Locations

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Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chaoyu Liu, PhD

Role: CONTACT

+8675588858978-808

Xiaohua Li, PhD

Role: CONTACT

+8675588858978-808

Facility Contacts

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Geng Tian, MD

Role: primary

Chaoyu Liu, PhD

Role: backup

References

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Peng M, Xie Y, Li X, Qian Y, Tu X, Yao X, Cheng F, Xu F, Kong D, He B, Liu C, Cao F, Yang H, Yu F, Xu C, Tian G. Resectable lung lesions malignancy assessment and cancer detection by ultra-deep sequencing of targeted gene mutations in plasma cell-free DNA. J Med Genet. 2019 Oct;56(10):647-653. doi: 10.1136/jmedgenet-2018-105825. Epub 2019 Apr 13.

Reference Type DERIVED
PMID: 30981987 (View on PubMed)

Other Identifiers

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GeneHealth-LC-01

Identifier Type: -

Identifier Source: org_study_id

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