PREcision Medicine in Cancer in Odense, Denmark

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

Sponsors

Lead Sponsor: Odense University Hospital

Source 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.

Overall Status Recruiting
Start Date 2019-03-01
Completion Date 2023-12-31
Primary Completion Date 2023-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Turn around time genomic profiling through study completion, an average of 2 year
Secondary Outcome
Measure Time Frame
Frequenc of matched treatment offer through study completion, an average of 2 year
Enrollment 900
Condition
Intervention

Intervention Type: Other

Intervention Name: genomic profiling

Description: next generation sequencing

Arm Group Label: genomic profiling

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Karin H Hansen Principal Investigator Departement of Oncology Odense University Hospital
Overall Contact

Last Name: Karin H Hansen

Phone: 0045 29173453

Email: [email protected]

Location
Facility: Status: Contact: Odense Universitets Hospital dept of oncology Karin H Hansen, MD 0045 29173453 [email protected]
Location Countries

Denmark

Verification Date

2022-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Odense University Hospital

Investigator Full Name: Karin Holmskov Hansen

Investigator Title: MD, Principal Investigator

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: genomic profiling

Type: Other

Description: 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.

Acronym PRECODE
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: prospective, single-center cohorte study

Primary Purpose: Diagnostic

Masking: None (Open Label)

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