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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT05926284

Collaborator

(none)

2,000

Enrollment

Location

180

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2030

Anticipated Study Completion Date :

Mar 1, 2031

Outcome Measures

Primary Outcome Measures

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

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
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
frequency of pharmacogenomic findings [At 1 year after study inclusion]
Number of participants with a recommendation for pharmacongenomic considerations a
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Comprehensive Cancer Center	Berlin		Germany	10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Damian Rieke, Speaker, Platform for personalized cancer therapy at Charité Comprehensive Cancer Center, Principal Investigator, Medical Doctor, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT05926284

Other Study ID Numbers:

3000764

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 3, 2023