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Recruiting

NCT Number: NCT02290522

Copenhagen Prospective Personalized Oncology (CoPPO)

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.

Recruiting

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Key information

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

Location status: Recruiting

Location contact

Ulrik Lassen, MD, PH.D

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor Biopsy

Procedure

Biopsy of lesion for molecular characterization

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ida V Tuxen, MD

CONTACT

+4535453545

Ulrik Lassen, MD, PH.D.

CONTACT

+4535453545

Sponsors and collaborators

Lead sponsor

Ulrik Lassen

Other

Registry information

Official study title

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

Acronym: CoPPO

Important dates

Study start
2013
Primary completion
2028
Study completion
2029
First posted
Nov 14, 2014
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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