PREcision Medicine in Cancer in Odense, Denmark (PRECODE)

PREcision Medicine in Cancer in Odense, Denmark (PRECODE) Feasibility of Genomic Profiling and Frequency of Genomic Matched Treatment in Solid Tumors With no Treatment Options

The traditional approach to cancer treatment has changes from using drugs approved for the specific cancer diagnosis to a tumor agnostic approach when treating solid tumors. How often will tumor biopsy and genomic profiling in patients with advanced solid tumors with no further evidence based treatment options result in biomarker-driven targeted treatment ? Feasibility of the investigation of patients and median turnaround time from biopsy to available genomic profile is evaluated.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Solid Tumor
• Intervention / Treatment: Other: genomic profiling

Detailed Description

Genomic profiling in patients with advanced solid tumors and no further evidence based treatment options is a newer approach. The frequency of genomic alterations varies between individual tumor types and the actionability of somatic variants are different but evolves in line with the development of new targeted drugs. In accordance with expected short survival short assessment time is important to minimize the risk of patient detoriation during the investigation. A fresh biopsy from lesions in progression is preferred for analysis. To minimize the duration of the genomic profiling a genpanel analysis covering the most frequent oncogene targets is preferred.

The primary objective is to evaluate the feasibility of the investigational procedures. The secondary objective is to investigate how often genomic changes in tumor tissue gives rise to a targeted treatment offer and to evaluate the clinical benefit using the Growth Modulation Index.

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karin H Hansen; Phone Number: 0045 29173453; Email: karin.holmskov@rsyd.dk

Study Locations

• Denmark
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense Universitets Hospital dept of oncology
    • Contact: Karin H Hansen, MD; Phone Number: 0045 29173453; Email: karin.holmskov@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• Age ≥ 18 years
• Diagnosis of advanced solid tumors
• Evidence based treatment options are exhausted
• Performance Status 0-2
• Adequate organ function
• Life expectancy of at least 3 months

Exclusion Criteria:

• inclusions criteria not met

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: genomic profiling; After informed consent a PET/CT scan is performed to determine disease spread and the best location for core needle biopsi. Genomic profiling is performed using Next Generation Sequencing, NGS, genpanel analysis by Oncomine Comprehensive vs 3 The result of NGS is discussed at weekly local and national tumor board meeting to decide a possible targeted treatment offer based on genomic profiling or a possibly treatment offer in a clinical trial. Timelines in the course of investigation will be calculated using date of informed consent, PET/CT scan, biopsy, tumor board and date of start of next treatment, progression and death. If the genomic profiling results in a targeted treatment offer the Growth Modulation Index is calculated from progressions-free survival on recent and current treatment. Treatment given without an actionable target is likewise evaluated for efficacy.

Other: genomic profiling; next generation sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Turn around time genomic profiling	Time from date of biopsi to date of available genomic profile discussed at tumor board meeting	through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequenc of matched treatment offer	Number of patients offered a treatment based on the genomic profile	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Karin H Hansen, Departement of Oncology Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PRECODE_S-20180147G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No