Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer

Study Overview
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Brief Summary
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Prospective observational study of a precision medicine approach in patients with advanced cancer. In this registrational study, patients with advanced cancer undergoing extensive molecular sequencing within the precision oncology program of Charité University Medicine, Berlin will be registered and followed to assess the efficacy of the program and assess the clinical relevance and frequency of molecular alterations, individualized therapies and novel molecular analysis tools.

Official Title
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Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: advanced cancer ability to give written informed consent performance status allows initiation of a potential targeted treatment after molecular analysis molecular analysis has been done or planned Exclusion Criteria: - unable to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of personalized treatment initiation | Frequency of personalized treatment initiation | At 1 year from date of study inclusion | 
| Frequency of molecularly stratified treatment options | Number of molecularly stratified treatment options per patient | At 1 year from date of study inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | From date of study inclusion until the date of first documented progression or date of death from any cause, whichever came first | Assessed up to 100 months | 
| PFS-ratio | Ratio of progression-free survival with molecularly matched therapy to progression-free survival with previous treatment line | Assessed up to 100 months | 
| objective response rate | Best radiographic response as assessed by the investigator | 1 year after study inclusion | 
| frequency of interventional study inclusion | Number of participants with inclusion in interventional clinical trial | At 1 year after study inclusion | 
| frequency of re-diagnosis | Number of participants with a change in diagnosis a | At 1 year after study inclusion | 
| frequency of recommendation of genetic counselling | Number of participants with a recommendation for genetic counselling | At 1 year after study inclusion | 
| frequency of pharmacogenomic findings | Number of participants with a recommendation for pharmacongenomic considerations a | At 1 year after study inclusion | 
| frequency and type of resistance mutations | Number of molecular alterations predicting resistance to molecularly matched therapy a | At 1 year after study inclusion | 
| overall survival | From date of study inclusion until the date of death from any cause, whichever came first | Assessed up to 100 months | 
| Evidence level of molecularly stratified treatment options | Frequency of evidence levels (according to NCT evidence levels) of molecularly stratified treatment options | At 1 year from study inclusion |