Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus
|ClinicalTrials.gov Identifier: NCT01300429|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2011
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment|
|Lung Cancer||Genetic: obtain tissue specimens|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
patients with Non Small Cell Lung cancer
This is a protocol to obtain and/or analyze tissue specimens of patients with NSCLC harboring an activating ALK inversion or translocation that have had a previous clinical response to tyrosine kinase inhibitor therapy and subsequently experience progressive disease. The tissue will be used to identify changes in the ALK gene that are acquired during treatment with an ALK TKI and may account for acquired resistance.
Genetic: obtain tissue specimens
One core biopsy specimen will be placed in formalin and processed for cytogenetic and FISH analyses as well as DNA for ALK sequencing. The second core biopsy specimen will be immediately frozen in liquid nitrogen and stored in a -80 degree freezer for research specimen. Collection will be performed on-site at the time of the procedure.
- the frequency of acquired mutations [ Time Frame: 2 years ]ALK sequence from tumor tissue pre-treatment in patients that respond to crizotinib will be compared to ALK sequence in tumor tissue after the development of resistance when there is persistence of the original ALK inversion or translocation event.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300429
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Gregory Riely, MD, PhD||Memorial Sloan Kettering Cancer Center|