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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Using Genomic Screening to Select Patients for Targeted Molecular Treatment
- ClinicalTrials.gov ID
- NCT02290522
- Acronym / sponsor ID
- CoPPO / 1300530
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ulrik LassenUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tumor biopsy | Experimental | Procedure: Tumor biopsyTumor biopsy for targeted treatment according to molecular profile |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Solid tumor
- No standard treatment option
- PS 0-1
- Lesion assessable for biopsy
- Measurable disease
Key exclusion criteria (4 listed)
- Life expectancy < 3 months
- Bone marrow suppression
- Abnormal renal or hepatic function
- Serious concurrent medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor biopsyBiopsy of lesion for molecular characterization | Procedure or surgery | tumor biopsy |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 36529989Jacobsen 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.
- Derived from this study: PubMed 30274980Tuxen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ida V Tuxen, MD contact
Ulrik Lassen, MD, PH.D. contact
Ulrik Lassen, MD, PH.D. principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor biopsy in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Ulrik Lassen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida V Tuxen, MD (+4535453545), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median progression free survival (PFS) (time frame: Median time from date of randomization to date of progression or death, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290522, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.