Clinical trial · Observational
Gene Mutations in Non-Small Cell Lung Cancer Cells
Detection of Gene Mutations in Non-small Cell Lung Cancer Cells in Blood Samples or Fine-needle Aspiration
NCT00977509CI-TRIAL-00012784unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the frequency of individual genetic abnormality between tumor cells and blood specimens.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the frequency of individual genetic abnormality in advanced non-small cell lung cancer (NSCLC) patients who will commence systemic therapy.
- timeFrame
- 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)
- measure
- 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.
- timeFrame
- 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.
- measure
- 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.
- timeFrame
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.