Status:
COMPLETED
Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology
Lead Sponsor:
iOMEDICO AG
Collaborating Sponsors:
Bristol-Myers Squibb
Roche Pharma AG
Conditions:
Advanced Solid Tumors or Hematologic Malignancies
Eligibility:
All Genders
18+ years
Brief Summary
The retrospective cohort study INFINITY will be an instrument to analyze the current practice of precision oncology in the real-world setting. It will provide insight into real-world biomarker-directe...
Eligibility Criteria
Inclusion
- Advanced solid tumors (i.e. locally advanced, inoperable and/or metastatic) or hematologic malignancies not eligible for standard therapy options (i.e. without further treatment options with drugs approved for the specific indication based on the judgement of the treating physician)
- Started or completed at the documenting study site a non-standard targeted therapy based on an actionable alteration or biomarker identified by molecular diagnostics
- Results on molecular diagnostics (e.g. tumor genomic or protein expression test) must be available; based on these results the therapy decision was taken
- Targeted therapy (given as monotherapy or as part of a therapy regimen) must be non-standard at time point of patient registration in the eCRF
- Age ≥ 18 years
- Signed and dated informed consent form (only if patient is alive at time of data entry into the project; not applicable for inclusion of deceased patients' data)
Exclusion
- Non-standard targeted therapy was given within a clinical trial
- The targeted therapy was given in a line of treatment for which it is non-standard (e.g. treatment in first line instead of second line where it is approved); the targeted therapy is however in principle approved for the given entity
- The targeted therapy was non-standard because a certain prior treatment has not been applied (e.g. targeted therapy is only approved after platin-based treatment but has been given without prior platin-based treatment); the targeted therapy is however in principle approved for the given entity
- The targeted therapy was non-standard because a different or no chemotherapy back-bone has been applied (e.g. targeted therapy is approved in combination with cisplatin but has been given with oxaliplatin or without chemotherapy backbone); the targeted therapy is however in principle approved for the given entity
Key Trial Info
Start Date :
April 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
499 Patients enrolled
Trial Details
Trial ID
NCT04389541
Start Date
April 17 2020
End Date
June 30 2023
Last Update
August 14 2023
Active Locations (97)
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1
MVZ am Klinikum Aschaffenburg
Aschaffenburg, Germany, 63739
2
Studienzentrum Aschaffenburg
Aschaffenburg, Germany, 63739
3
Onkologische Schwerpunktpraxis
Augsburg, Germany, 86152
4
Hämatologisch-Onkologische Schwerpunktpraxis Bad Liebenwerda
Bad Liebenwerda, Germany, 04924