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NCT Number: NCT05926284

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of personalized treatment initiation

    Time frame: At 1 year from date of study inclusion

    Frequency of personalized treatment initiation

  2. Frequency of molecularly stratified treatment options

    Time frame: At 1 year from date of study inclusion

    Number of molecularly stratified treatment options per patient

Secondary outcomes

  1. Progression free survival

    Time frame: 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

  2. PFS-ratio

    Time frame: Assessed up to 100 months

    Ratio of progression-free survival with molecularly matched therapy to progression-free survival with previous treatment line

  3. objective response rate

    Time frame: 1 year after study inclusion

    Best radiographic response as assessed by the investigator

  4. frequency of interventional study inclusion

    Time frame: At 1 year after study inclusion

    Number of participants with inclusion in interventional clinical trial

  5. frequency of re-diagnosis

    Time frame: At 1 year after study inclusion

    Number of participants with a change in diagnosis a

  6. frequency of recommendation of genetic counselling

    Time frame: At 1 year after study inclusion

    Number of participants with a recommendation for genetic counselling

  7. frequency of pharmacogenomic findings

    Time frame: At 1 year after study inclusion

    Number of participants with a recommendation for pharmacongenomic considerations a

  8. frequency and type of resistance mutations

    Time frame: At 1 year after study inclusion

    Number of molecular alterations predicting resistance to molecularly matched therapy a

  9. overall survival

    Time frame: Assessed up to 100 months

    From date of study inclusion until the date of death from any cause, whichever came first

  10. Evidence level of molecularly stratified treatment options

    Time frame: At 1 year from study inclusion

    Frequency of evidence levels (according to NCT evidence levels) of molecularly stratified treatment options

Study contacts

Contact information is provided by the study sponsor or research team.

Damian T Rieke, MD

CONTACT

[email protected]

+49 (0)30 450 564 222

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: PRIME

Important dates

Study start
2016
Primary completion
2030
Study completion
2031
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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