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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| genomic profiling | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genomic profiling | Other | next generation sequencing |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• inclusions criteria not met
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karin H Hansen | Contact | 0045 29173453 | karin.holmskov@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Karin H Hansen | Departement of Oncology Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense Universitets Hospital dept of oncology | Recruiting | Odense C | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39574115 | Derived | Hansen KH, Lyng MB, Kodahl AR, Asmussen JT, Arshad A, Petersen H, Krogh L, Ehmsen S, Kristensen TK, Ditzel HJ. Genomic profiling and expanded use of targeted anticancer drugs in solid cancers with exhausted evidence-based treatment options (PRECODE): study protocol of a prospective, non-randomized, cohort study. BMC Med Genomics. 2024 Nov 21;17(1):274. doi: 10.1186/s12920-024-02033-z. |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000076610 | Genetic Profile |
| ID | Term |
|---|---|
| D000068617 | Genetic Background |
| D055614 | Genetic Phenomena |
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prospective, single-center cohorte study
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