Copenhagen Prospective Personalized Oncology (CoPPO)

Ulrik Lassen

Status: Enrolling

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Procedure: Tumor biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02290522

1300530

Details and patient eligibility

About

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.

Full 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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Solid tumor
• No standard treatment option
• PS 0-1
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

tumor biopsy

Experimental group

Description:

Tumor biopsy for targeted treatment according to molecular profile

Treatment:

Procedure: Tumor biopsy