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Copenhagen Prospective Personalized Oncology (CoPPO) (CoPPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290522
Recruitment Status : Recruiting
First Posted : November 14, 2014
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Ulrik Lassen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Procedure: Tumor biopsy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study Using Genomic Screening to Select Patients for Targeted Molecular Treatment
Study Start Date : May 2013
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: tumor biopsy
Tumor biopsy for targeted treatment according to molecular profile
Procedure: Tumor biopsy
Biopsy of lesion for molecular characterization




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290522


Contacts
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Contact: Ida V Tuxen, MD +4535453545
Contact: Ulrik Lassen, MD, PH.D. +4535453545

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Principal Investigator: Ulrik Lassen, MD, PH.D         
Sponsors and Collaborators
Ulrik Lassen
Investigators
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Principal Investigator: Ulrik Lassen, MD, PH.D. Rigshospitalet, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ulrik Lassen, MD, PH.D, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02290522    
Other Study ID Numbers: 1300530
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020