A Prospective Study Using Genomic Screening to Select Patients for Targeted Molecular Treatment
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Sponsor
- Ulrik Lassen
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Median progression free survival (PFS)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA for identification of pts who could benefit from a personalized treatment.
Detailed Description
Two ultrasound-guided biopsies obtained to be stored in RNAlater® for DNA and RNA purification. A 3rd biopsy for histology is paraffin embedded. SNP-array (Affymetrix Cytoscan HD) from DNA (tumor) is performed to identify copy number changes. Whole exome sequencing (WES) from DNA (tumor and blood) will be performed using sequence capture, SureSelect v5 (Agilent) and Illumina HiSeq2500 to call tumor specific mutations. Expression levels of therapeutic targets are revealed by expression Array from tumor RNA. In addition to the expression array, RNA-seq (Nugens Ovation RNA-seq system v2) is performed to investigate whether chromosomal translocations were the reason for tumor specific expression of an oncogene. Results will be reviewed by a tumor board. Patients with specific genetic profiles that can be targeted with marketed drugs or drugs under development are offered such treatment. PFS from the treatment is compared to PFS of the most recent standard treatment (PFS ratio).
Investigators
Ulrik Lassen
MD, PH.D
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Solid tumor
- •No standard treatment option
- •Lesion assessable for biopsy
- •Measurable disease
- •Informed consent
Exclusion Criteria
- •Life expectancy \< 3 months
- •Bone marrow suppression
- •Abnormal renal or hepatic function
- •Serious concurrent medical conditions
Outcomes
Primary Outcomes
Median progression free survival (PFS)
Time Frame: Median time from date of randomization to date of progression or death, assessed up to 100 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months