Copenhagen Prospective Personalized Oncology (CoPPO)

NCT ID: NCT02290522

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2023-12-31

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.

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).

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

tumor biopsy

Tumor biopsy for targeted treatment according to molecular profile

Group Type: EXPERIMENTAL

Tumor biopsy

Intervention Type: PROCEDURE

Biopsy of lesion for molecular characterization

Interventions

Tumor biopsy

Biopsy of lesion for molecular characterization

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ulrik Lassen

OTHER

Sponsor Role: lead

Responsible Party

Ulrik Lassen

MD, PH.D

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ulrik Lassen, MD, PH.D.

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ida V Tuxen, MD

Role: CONTACT

+4535453545

Ulrik Lassen, MD, PH.D.

Role: CONTACT

+4535453545

References

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.

Reference Type: DERIVED

PMID: 36529989 (View on PubMed)

Tuxen 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.

Reference Type: DERIVED

PMID: 30274980 (View on PubMed)

Other Identifiers

1300530

Identifier Type: -

Identifier Source: org_study_id