Gene Mutations in Non-Small Cell Lung Cancer Cells

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Detection of Gene Mutations in Non-small Cell Lung Cancer Cells in Blood Samples or Fine-needle Aspiration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00977509
• Other study ID #: 200812092R
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2009
• Last updated: November 29, 2013
• Start date: November 2009
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: National Taiwan University Hospital
• Contact: Ya-Ying Bai, M.S.
• Phone: 886-23123456
• Email: yaying0508[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the frequency of individual genetic abnormality in advanced non-small cell lung cancer (NSCLC) patients who will commence systemic therapy.		Samples will be collected before the systemic therapy, at the end of the first three months and once every 3 months. In selected consented patients, peripheral blood samples will be collected every week for the first month.	No
Secondary	To determine the frequency with which molecular profiling of a NSCLC patient's tumor by DNA sequencing and/or FISH yields a target against which there is approved or investigational therapeutic regimen.		Samples will be collected before the systemic therapy, at the end of the first three months and once every 3 months. In selected consented patients, peripheral blood samples will be collected every week for the first month.	No
Secondary	To determine the response rate according to RECIST, progression-free, and overall survival in patients with advanced NSCLC whose therapy is selected by molecular profile.		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.	Yes