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

Recruiting

• Conditions: Cancer

• Registration Number: NCT05926284
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2023-04-08
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-21
• Last Update Submitted: 2023-06-21
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03
• Primary Completion: 2030-03-01
• Study Completion: 2031-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
PFS-ratio	Assessed up to 100 months	Ratio of progression-free survival with molecularly matched therapy to progression-free survival with previous treatment line
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
frequency of pharmacogenomic findings	At 1 year after study inclusion	Number of participants with a recommendation for pharmacongenomic considerations a
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
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 and type of resistance mutations	At 1 year after study inclusion	Number of molecular alterations predicting resistance to molecularly matched therapy a

Trial Locations

Locations (1)

Charité Comprehensive Cancer Center; 🇩🇪 Berlin, Germany