Copenhagen Prospective Personalized Oncology (CoPPO)

Not Applicable

Recruiting

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Procedure: Tumor biopsy

• Registration Number: NCT02290522
• Lead Sponsor: Ulrik Lassen

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).

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tumor biopsy	Tumor biopsy	Tumor biopsy for targeted treatment according to molecular profile

Primary Outcome Measures

Name	Time	Method
Median progression free survival (PFS)	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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark