Unspecified Adult Solid Tumor, Protocol SpecificCoPPONCT02290522
Copenhagen Prospective Personalized Oncology (CoPPO)
A study testing Tumor biopsy in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Ulrik Lassen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Tumor biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2013to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid tumor
- No standard treatment option
- PS 0-1
- Lesion assessable for biopsy
- Measurable disease
- Informed consent
Who cannot join
- Life expectancy < 3 months
- Bone marrow suppression
- Abnormal renal or hepatic function
- Serious concurrent medical conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ida V Tuxen, MD contact
Ulrik Lassen, MD, PH.D. contact
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Ulrik Lassen, MD, PH.D
About this study
Official title: A Prospective Study Using Genomic Screening to Select Patients for Targeted Molecular Treatment
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.
Read the 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).
- Being tested
- Tumor biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biopsyProcedure or surgery
Biopsy of lesion for molecular characterization
| Study group | Role | What they receive |
|---|---|---|
| tumor biopsy | Experimental | Tumor biopsy for targeted treatment according to molecular profile Receives: Procedure: Tumor biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Median time from date of randomization to date of progression or death, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study start1 May 2013
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulrik Lassen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulrik Lassen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulrik Lassen, MD, PH.D., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290522
- Sponsor's protocol ID
- 1300530
- Acronym
- CoPPO
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2014
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacobsen IC, Spanggaard I, Hojgaard M, Belcaid L, Qvortrup C, Yde CW, Schmidt AY, Nielsen FC, Willemoe GL, Dam MS, Lassen U, Staal Rohrberg K. Extensive genomic analysis in patients with KRAS-mutated solid tumors shows high frequencies of concurrent alterations and potential targets but has limited clinical impact. Acta Oncol. 2022 Dec;61(12):1499-1506. doi: 10.1080/0284186X.2022.2156809. Epub 2022 Dec 18.
PubMed 36529989Tuxen IV, Rohrberg KS, Oestrup O, Ahlborn LB, Schmidt AY, Spanggaard I, Hasselby JP, Santoni-Rugiu E, Yde CW, Mau-Sorensen M, Nielsen FC, Lassen U. Copenhagen Prospective Personalized Oncology (CoPPO)-Clinical Utility of Using Molecular Profiling to Select Patients to Phase I Trials. Clin Cancer Res. 2019 Feb 15;25(4):1239-1247. doi: 10.1158/1078-0432.CCR-18-1780. Epub 2018 Oct 1.
PubMed 30274980