PREcision Medicine in Cancer in Odense, Denmark

Not Applicable

• Conditions: Metastatic Solid Tumor
• Interventions: Other: genomic profiling

• Registration Number: NCT05385081
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2022-01-07
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

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Exclusion Criteria

• inclusions criteria not met

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
genomic profiling	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Frequenc of matched treatment offer	through study completion, an average of 2 year	Number of patients offered a treatment based on the genomic profile

Trial Locations

Locations (1)

Odense Universitets Hospital dept of oncology; 🇩🇰 Odense C, Denmark