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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Damian T Rieke, MD; Phone Number: +49 (0)30 450 564 222; Email: cccc@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charite Comprehensive Cancer Center
    • Contact: Damian T Rieke, MD; Phone Number: +49 (0)30 450 564 222; Email: cccc@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced cancer presenting to the precision oncology program at Charité for molecular analyses to identify personalized treatment options.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: April 8, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 3000764

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No