Cancer
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of personalized treatment initiation | At 1 year from date of study inclusion | Frequency of personalized treatment initiation |
| Frequency of molecularly stratified treatment options | At 1 year from date of study inclusion | Number of molecularly stratified treatment options per patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 1 year after study inclusion | Best radiographic response as assessed by the investigator |
| frequency of interventional study inclusion | At 1 year after study inclusion | Number of participants with inclusion in interventional clinical trial |
| frequency of re-diagnosis | At 1 year after study inclusion | Number of participants with a change in diagnosis a |
| frequency of recommendation of genetic counselling | At 1 year after study inclusion | Number of participants with a recommendation for genetic counselling |
| Progression free survival | Assessed up to 100 months | From date of study inclusion until the date of first documented progression or date of death from any cause, whichever came first |
| frequency and type of resistance mutations | At 1 year after study inclusion | Number of molecular alterations predicting resistance to molecularly matched therapy a |
| overall survival | Assessed up to 100 months | From date of study inclusion until the date of death from any cause, whichever came first |
| Evidence level of molecularly stratified treatment options | At 1 year from study inclusion | Frequency of evidence levels (according to NCT evidence levels) of molecularly stratified treatment options |
| frequency of pharmacogenomic findings | At 1 year after study inclusion | Number of participants with a recommendation for pharmacongenomic considerations a |
| PFS-ratio | Assessed up to 100 months | Ratio of progression-free survival with molecularly matched therapy to progression-free survival with previous treatment line |
Countries
Germany
Contacts
Primary ContactDamian T Rieke, MD
Outcome results
None listed