Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Frequency of personalized treatment initiation [Time frame: At 1 year from date of study inclusion]
- Frequency of molecularly stratified treatment options [Time frame: At 1 year from date of study inclusion]
Secondary outcome measures (10)
- Progression free survival [Time frame: Assessed up to 100 months]
- PFS-ratio [Time frame: Assessed up to 100 months]
- objective response rate [Time frame: 1 year after study inclusion]
- frequency of interventional study inclusion [Time frame: At 1 year after study inclusion]
- frequency of re-diagnosis [Time frame: At 1 year after study inclusion]
- frequency of recommendation of genetic counselling [Time frame: At 1 year after study inclusion]
- frequency of pharmacogenomic findings [Time frame: At 1 year after study inclusion]
- frequency and type of resistance mutations [Time frame: At 1 year after study inclusion]
- overall survival [Time frame: Assessed up to 100 months]
- Evidence level of molecularly stratified treatment options [Time frame: At 1 year from study inclusion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Charité Comprehensive Cancer Center — Berlin
Identifiers
NCT: NCT05926284 · 3000764