Adenocarcinoma of Lung, ALK Genes, Cancer of Lung, EGFR Genes, Lung Cancer, Lung Neoplasm, Pulmonary Cancer
Conditions
Brief summary
Patients are asked to participate in this study if they have been diagnosed with a thoracic carcinoma which includes lung cancer and have a gene mutation (alteration in the body's genetic instructions) and after undergoing treatment the cancer has come back, progressed, or shown a partial response on standard treatment.
Detailed description
In order to improve the treatment outcome for thoracic carcinomas after they become resistant to targeted therapy, the investigator is using tumor biopsies at the time of recurrence for genomic analysis to identify novel somatic changes in critical genes and gene pathways that can potentially be targeted with therapy. The study team is also creating patient-derived xenografts to test drug efficacy and optimize personalized therapy for each patient.
Interventions
None listed
Sponsors
National Foundation for Cancer Research
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Thoracic carcinoma tumors are positive for any targetable genetic alterations * Have shown partial or no response, progression or recurrence while on or after gene targeted therapy by CT/PET scan * Tumor is accessible for biopsy or surgery * Expected life is 6 months or longer.
Exclusion criteria
* \< 18 years * Not able to communicate in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify the number of molecular changes in the recurrent tumor through molecular analysis with gene panels. | 1 Year | To determine molecular changes in the recurrent tumor, identify the most significant genes and pathways and clinical phenotypes in lung adenocarcinomas resistant to tyrosine kinase inhibitor treatment. |
| Number of tumorgrafts from biopsies of the recurrent tumor grown and used for drug treatment selection based on genomic signatures. | 1 Year | Mice will be used to grow tumor xenografts. For subsequent passages, tumors will be implanted through passage mice. The patient-derived xenograft-baring mice will then be used for anti-tumor efficacy studies according to the patient prior therapeutic history and molecular signature of the tumor biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recording turn-around-time | 1 year | Time metrics from biopsy to completion of molecular genetic tests; the time and the success rate of tumorgraft growth in mice as well as the optimal time lapse between initiation treatment to observation of response will be examined. This will aid in the determination of feasibility and opportunities of using patient specific treatment for tumor recurrence. |
Countries
United States
Outcome results
None listed