ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC

NCT ID: NCT02946216

Last Updated: 2016-10-27

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-11-30

Brief Summary

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The study aims to explore the prevalence of ALK/ROS1/MET mutations assessed with ctDNA samples in EGFR-wildtype NSCLC

Detailed Description

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Conditions

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Non-small Cell Lung Cancer Stage III Non-Small-Cell Lung Cancer Metastatic Adenocarcinoma of Lung EGFR Wildtype

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ctDNA analysis

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed stage IIIB/IV NSCLC;
* Histologically confirmed adenocarcinoma;
* EGFR-wildtype NSCLC;
* Provision of blood (plasma) sample for ctDNA testing;
* Patient must be able to comply with the protocol;
* Provision of blood (plasma) sample for ctDNA testing;

Exclusion Criteria

* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
* Histologically confirmed small cell lung cancer or other metastatic tumors;
* Patient with no histologic or cytological diagnosis;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First People's Hospital of Hangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hangzhou First People's Hospital, Nanjing Medical University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Shenglin Ma, M.D

Role: CONTACT

Phone: 057156007908

Email: [email protected]

Facility Contacts

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Shirong Zhang, Ph.D

Role: primary

Other Identifiers

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2016-101-01

Identifier Type: -

Identifier Source: org_study_id