Multiplex Analysis of Circulating Tumor DNA

NCT ID: NCT03301961

Last Updated: 2020-02-05

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

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-11

Study Completion Date

2022-06-01

Brief Summary

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Lung cancer is the leading cause of cancer-related death in China. This study will explore the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and surveillance of lung cancer patients

Detailed Description

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Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung cancer and continues to be the leading cause of cancer-related deaths worldwide.Early diagnosis and monitoring tumor recurrence after surgery are still far from satisfying.

Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this study will perform multiplex detection of ctDNA,analysing mutations, methylation and other biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.

Conditions

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Carcinoma Non-small-cell Lung Cancer Lung Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Sign informed consent and consent to participate in this study;
2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion Criteria

1. Malignant tumor history within the past 5 years;
2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
3. No matching tissue or blood samplesUnqualified blood samples
4. Lesion is pure ground glass opacity.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun Wang

Chief,Thoracic Surgery Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kezhong Chen, MD

Role: STUDY_DIRECTOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kezhong Chen, MD

Role: CONTACT

(+86)13488752289

Heng Zhao, MD

Role: CONTACT

(+86)13683139396

Facility Contacts

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Kezhong Chen, M.D.

Role: primary

+8613488752289

Other Identifiers

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PTHO1701

Identifier Type: -

Identifier Source: org_study_id

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