Gene Mutations in Non-Small Cell Lung Cancer Cells

NCT00977509 | Unknown

• 1 other identifier: 200812092R
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

genes; mutation; non-small cell lung cancer; cancer cells

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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.

• 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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, pleural fluid, and biopsy.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chih-Hsin Yang, M.D., ph.D.

  National Taiwan University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Ying Bai, M.S.

CONTACT

886-23123456; yaying0508@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 15, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 2, 2013

Record last verified: 2013-11

Locations

TW (1)