Copenhagen Prospective Personalized Oncology (CoPPO)

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

— CoPPO  

Official title:

A Prospective Study Using Genomic Screening to Select Patients for Targeted Molecular Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02290522
• Other study ID #: 1300530
• Status: Recruiting
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Rigshospitalet, Denmark
• Contact: Ida V Tuxen, MD
• Phone: +4535453545
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• Tumor biopsy
Biopsy of lesion for molecular characterization

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Ulrik Lassen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median progression free survival (PFS)	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	Median time from date of randomization to date of progression or death, assessed up to 100 months