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Gene Mutations in Non-Small Cell Lung Cancer Cells

NCT ID: NCT00977509

Last Updated: 2013-12-02

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

2009-11-30

Study Completion Date

2014-12-31

Brief Summary

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To compare the frequency of individual genetic abnormality between tumor cells and blood specimens.

Detailed Description

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Samples will be collected before the systemic therapy. After initiation of therapy, samples will be collected at end of the 1st month, at the end of the 2nd month at the end of 3rd months and once every three months thereafter concurrently with the tumor assessment such as time of performing CT scans. In selected consented patients, peripheral blood samples will be collected every week for the first month.

Disease status will be assessed every 2\~3 months and at the end of treatment according to RECIST criteria. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. Progression-free survival, overall survival and response rate will be reported.

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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genes mutation non-small cell lung cancer cancer cells

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pathologic or cytological confirmation of NSCLC.
* Patients must understand and provide written informed consent prior to initiation of any study-specific procedures.
* Have a life expectancy 3 months.
* Have malignant pleural/pericardial effusion or metastatic non-small cell lung cancer.
* Have measurable or evaluable disease.
* ≥20 years.
* Candidate for systemic treatment such as EGFR-TKI or chemotherapy.

Exclusion Criteria

* Prior history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chih-Hsin Yang, M.D., ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University College of Medicine

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ya-Ying Bai, M.S.

Role: CONTACT

Phone: 886-23123456

Email: [email protected]

Facility Contacts

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Chih-Hsin Yang, M.D., Ph.D.

Role: primary

Other Identifiers

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200812092R

Identifier Type: -

Identifier Source: org_study_id