CancerPRIMENCT05926284
Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer
An observational study of Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2016to 1 Mar 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with advanced cancer presenting to the precision oncology program at Charité for molecular analyses to identify personalized treatment options.
Who may be able to join
- 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
Who cannot join
- unable to give written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité Comprehensive Cancer Center
Berlin, 10117
Damian T Rieke, MD, +49 (0)30 450 564 222, cccc@charite.de
About this study
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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of personalized treatment initiation
Frequency of personalized treatment initiation
Measured: At 1 year from date of study inclusion
Frequency of molecularly stratified treatment options
Number of molecularly stratified treatment options per patient
Measured: At 1 year from date of study inclusion
Secondary outcomes (10)
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
Measured: Assessed up to 100 months
PFS-ratio
Ratio of progression-free survival with molecularly matched therapy to progression-free survival with previous treatment line
Measured: Assessed up to 100 months
objective response rate
Best radiographic response as assessed by the investigator
Measured: 1 year after study inclusion
frequency of interventional study inclusion
Number of participants with inclusion in interventional clinical trial
Measured: At 1 year after study inclusion
frequency of re-diagnosis
Number of participants with a change in diagnosis a
Measured: At 1 year after study inclusion
frequency of recommendation of genetic counselling
Number of participants with a recommendation for genetic counselling
Measured: At 1 year after study inclusion
frequency of pharmacogenomic findings
Number of participants with a recommendation for pharmacongenomic considerations a
Measured: At 1 year after study inclusion
frequency and type of resistance mutations
Number of molecular alterations predicting resistance to molecularly matched therapy a
Measured: At 1 year after study inclusion
overall survival
From date of study inclusion until the date of death from any cause, whichever came first
Measured: 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
Measured: At 1 year from study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Mar 2016
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damian Rieke, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926284
- Sponsor's protocol ID
- 3000764
- Acronym
- PRIME
- Status last verified
- Jun 2023
- First submitted
- 8 Apr 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05926284
- Acronym / sponsor ID
- PRIME / 3000764
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced cancer presenting to the precision oncology program at Charité for molecular analyses to identify personalized treatment options.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- unable to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of personalized treatment initiation
Time frame: At 1 year from date of study inclusion
Frequency of personalized treatment initiation
Frequency of molecularly stratified treatment options
Time frame: At 1 year from date of study inclusion
Number of molecularly stratified treatment options per patient
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damian T Rieke, MD (+49 (0)30 450 564 222, cccc@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of personalized treatment initiation (time frame: At 1 year from date of study inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.