Copenhagen Prospective Personalized Oncology (CoPPO)

Sponsor

Ulrik Lassen (Other)

Overall Status

Recruiting

CT.gov ID

NCT02290522

Collaborator

(none)

500

Enrollment

Location

Arm

115

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: tumor biopsy

Tumor biopsy for targeted treatment according to molecular profile

Procedure: Tumor biopsy

Biopsy of lesion for molecular characterization

Outcome Measures

Primary Outcome Measures

Median progression free survival (PFS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark

Sponsors and Collaborators

Ulrik Lassen

Investigators

Principal Investigator: Ulrik Lassen, MD, PH.D., Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ulrik Lassen, MD, PH.D, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT02290522

Other Study ID Numbers:

1300530

First Posted:

Nov 14, 2014

Last Update Posted:

Oct 6, 2020

Last Verified:

Oct 1, 2020

Study Results

No Results Posted as of Oct 6, 2020