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


N/A
20 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To determine the frequency of individual genetic abnormality in advanced non-small cell lung cancer (NSCLC) patients who will commence systemic therapy.

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University College of Medicine

Authority:

Taiwan: Department of Health

Study ID:

200812092R

NCT ID:

NCT00977509

Start Date:

November 2009

Completion Date:

June 2013

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • genes
  • mutation
  • non-small cell lung cancer
  • cancer cells
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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