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

Cancer Clinical Trial

— PRIME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926284
• Other study ID #: 3000764
• Status: Recruiting
• Start date: March 1, 2016
• Est. completion date: March 1, 2031

Study information

• Verified date: June 2023
• Source: Charite University, Berlin, Germany
• Contact: Damian T Rieke, MD
• Phone: +49 (0)30 450 564 222
• Email: cccc[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 1, 2031
• Est. primary completion date: March 1, 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Germany	Charité Comprehensive Cancer Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of personalized treatment initiation	Frequency of personalized treatment initiation	At 1 year from date of study inclusion
Primary	Frequency of molecularly stratified treatment options	Number of molecularly stratified treatment options per patient	At 1 year from date of study inclusion
Secondary	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
Secondary	PFS-ratio	Ratio of progression-free survival with molecularly matched therapy to progression-free survival with previous treatment line	Assessed up to 100 months
Secondary	objective response rate	Best radiographic response as assessed by the investigator	1 year after study inclusion
Secondary	frequency of interventional study inclusion	Number of participants with inclusion in interventional clinical trial	At 1 year after study inclusion
Secondary	frequency of re-diagnosis	Number of participants with a change in diagnosis a	At 1 year after study inclusion
Secondary	frequency of recommendation of genetic counselling	Number of participants with a recommendation for genetic counselling	At 1 year after study inclusion
Secondary	frequency of pharmacogenomic findings	Number of participants with a recommendation for pharmacongenomic considerations a	At 1 year after study inclusion
Secondary	frequency and type of resistance mutations	Number of molecular alterations predicting resistance to molecularly matched therapy a	At 1 year after study inclusion
Secondary	overall survival	From date of study inclusion until the date of death from any cause, whichever came first	Assessed up to 100 months
Secondary	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