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 |
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| 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. |
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| 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 |
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| Secondary Outcome |
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| Enrollment | 900 |
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| 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 |
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| Overall Contact |
Last Name: Karin H Hansen Phone: 0045 29173453 Email: [email protected] |
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| Location |
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| Location Countries |
Denmark |
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| 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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