Clinical trial NCT04389541: Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology
Official title: Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Solid Tumors or Hematologic Malignancies
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
name: Roche Pharma AG
First posted: 2020-05-15
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with advanced solid tumors or hematologic malignancies not eligible for standard therapies who received a targeted therapy based on an actionable alteration or biomarker identified by molecular diagnostics

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-directed treatment of cancer patients not eligible for standard therapies. The study will retrospectively collect medical records' data of patients who received a targeted treatment based on a potentially actionable alteration or biomarker identified by molecular diagnostics. Data of deceased patients will be included. The study will analyze how molecular test results guided clinical decision making. The compiled treatment and outcome data will be a valuable resource to analyze the use and effectiveness of targeted therapy approaches in biomarker-defined and entity-defined subpopulations of cancer patients. These signals might generate new insights and foster progress of targeted cancer treatment. The associated biomarker profiling module aims to set up a decentral biobank for future research on molecular alterations or central re-testing.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Overall response rate
timeFrame: Maximum 5 years
Secondary outcomes:
measure: Patient and Disease Characteristics
timeFrame: maximum 5 years
measure: Details on molecular diagnostics
timeFrame: Maximum 5 years
measure: Clinical decision making
timeFrame: Maximum 5 years (once per targeted therapy)
measure: Evaluation of selected treatment approach assessed via project specific survey
timeFrame: Maximum 5 years (once per completed targeted therapy)
measure: Best overall response
timeFrame: Maximum 5 years
measure: Disease Control Rate
timeFrame: Maximum 5 years
measure: Time to Response
timeFrame: Maximum 5 years
measure: Duration of Response
timeFrame: Maximum 5 years
measure: Time to treatment failure
timeFrame: Maximum 5 years
measure: Progression-free survival
timeFrame: Maximum 5 years
measure: PFS ratio
timeFrame: Maximum 5 years
measure: Overall Survival
timeFrame: Maximum 5 years
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: MVZ am Klinikum Aschaffenburg
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg
city: Augsburg
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Bad Liebenwerda
country: Germany
facility: Hämatologisch-Onkologische Schwerpunktpraxis Bad Liebenwerda
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gemeinnützige GmbH
city: Bamberg
country: Germany
facility: Onkologische Schwerpunktpraxis Bamberg
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth; Klinik für Onkologie und Hämatologie
city: Berlin
country: Germany
facility: Onkologisches Versorgungszentrum Friedrichshain
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Berlin
country: Germany
facility: Gemeinschaftspraxis für Onkologie und Hämatologie
city: Berlin
country: Germany
facility: Evangelisches Waldkrankenhaus,Spandau,Innere Medizin I
city: Berlin
country: Germany
facility: MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
city: Bremen
country: Germany
facility: Onkologisch-Hämatologische Schwerpunktpraxis
city: Coburg
country: Germany
facility: Klinikum Coburg Hämatologie, Onkologie
city: Coburg
country: Germany
facility: Schwerpunktpraxis für Hämatologie und internistische Onkologie Coburg
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt, Onkologisches Studienzentrum
city: Deggendorf
country: Germany
facility: Onkologisches Zentrum Deggendorf
city: Dresden
country: Germany
facility: Onkozentrum Dresden/Freiberg
city: Dresden
country: Germany
facility: BAG / Onkologische Gemeinschaftspraxis
city: Dresden
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Düsseldorf
country: Germany
facility: MVZ Onkologie und Hämatologie am Sana Krankenhaus Gerresheim
city: Ebersberg
country: Germany
facility: Praxis und Tagesklinik für gynäkologische Onkologie
city: Frankfurt a.M.
country: Germany
facility: Studienbüro CHOP GmbH
city: Frankfurt a.M.
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Frankfurt a.M.
country: Germany
facility: Universitätsklinikum Frankfurt; Medizinische Klinik 1: Pneumologie, Gastroenterologie, Hepatologie
city: Frankfurt a.M.
country: Germany
facility: Universitätsklinikum Frankfurt; Medizinische Klinik 2, Hämatologie, Onkologie
city: Freiburg
country: Germany
facility: Praxis für interdisziplinäre Onkologie & Hämatologie
city: Garbsen
country: Germany
facility: Gemeinschaftspraxis Panagiotou/Minaei (GbR)
city: Georgsmarienhütte
country: Germany
facility: MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie
city: Gerlingen
country: Germany
facility: Gemeinschaftspraxis Dres. Schmitt und Eulenbruch
city: Goslar
country: Germany
facility: Überörtliche Berufsausübungsgemeinschaft, MVZ Onkologische Kooperation Harz
city: Göttingen
country: Germany
facility: OSP Göttingen Dres. Meyer / Ammon / Metz
city: Halle (Saale)
country: Germany
facility: Gemeinschaftspraxis für Innere Medizin, Hämatologie, Onkologie, Gastroenterologie
city: Hamburg
country: Germany
facility: Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
city: Hamburg
country: Germany
facility: Studiengesellschaft Hämato-Onkologie Hamburg Prof. Laack & Partner GbR
city: Hamburg
country: Germany
facility: Hämatologisch-Onkologische Praxis Altona (HOPA)
city: Hannover
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Hannover
country: Germany
facility: MediProjekt GbR
city: Hannover
country: Germany
facility: Gemeinschaftspraxis Dr. Haytham Kamal und Dr. David C. Dorn
city: Heidelberg
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Heilbronn
country: Germany
facility: SLK Kliniken Heilbronn Klinik für Innere Medizin III
city: Herrsching
country: Germany
facility: Cancer Center Zweiseenland GbR
city: Hildesheim
country: Germany
facility: Onkologische Schwerpunktpraxis im Medicinum
city: Kaiserslautern
country: Germany
facility: Onkologische Schwerpunktpraxis Dres. Hansen & Reeb
city: Kassel
country: Germany
facility: Klinikum Kassel, Klinik für Onkologie und Hämatologie
city: Krefeld
country: Germany
facility: MVZ Hämatologie und Onkologie Dr. Michael Neise & Dr. André Lollert
city: Köln
country: Germany
facility: PIOH - Praxis Internistische Onkologie und Hämatologie
city: Köln
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie, München MVZ GmbH
city: Köthen
country: Germany
facility: Internisten am Markt
city: Landshut
country: Germany
facility: ÜBAG - MVZ Dr. Vehling-Kaiser GmbH
city: Lebach
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie GbR
city: Leer
country: Germany
facility: Onkologie UnterEms Leer-Emden-Papenburg
city: Leipzig
country: Germany
facility: MVZ Mitte am Johannisplatz
city: Mannheim
country: Germany
facility: Mannheimer Onkologie Praxis
city: Moers
country: Germany
facility: Gemeinschaftspraxis für Hämatologie & Onkologie
city: Mönchengladbach
country: Germany
facility: Brustzentrum Niederrhein im evangelischen Krankenhaus Bethesda
city: Mönchengladbach
country: Germany
facility: Praxis für Hämatologie, Onkologie & Palliativmedizin
city: Mönchengladbach
country: Germany
facility: MVZ Onkologie GmbH am Elisabeth-Krankenhaus Rheydt
city: Mülheim an der Ruhr
country: Germany
facility: Gemeinschaftspraxis für Hämatologie internistische Onkologie
city: München
country: Germany
facility: Medizinisches Zentrum für Hämatologie und Onkologie
city: Münster
country: Germany
facility: Hämatologisch-onkologische Gemeinschaftspraxis
city: Neumünster
country: Germany
facility: Friedrich-Ebert-Krankenhaus
city: Neuss
country: Germany
facility: TZN - Tumorzentrum Niederrhein GmbH
city: Neustadt Am Rübenberge
country: Germany
facility: MVZ Onko Medical GmbH Neustadt Innere, Med./Hämatologie-Onkologie
city: Neustadt i.S.
country: Germany
facility: Internistische Praxis und Tagesklinik
city: Offenburg
country: Germany
facility: Onkologie Offenburg Ambulantes Therapiezentrum für Hämatologie und Onkologie
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg Hämatologie, Onkologie
city: Passau
country: Germany
facility: Onkologische Praxis Passau
city: Porta Westfalica
country: Germany
facility: Zentrum für Hämatologie und Onkologie MVZ GmbH
city: Potsdam
country: Germany
facility: MVZ für Blut- und Krebserkrankungen
city: Ratingen
country: Germany
facility: Dr. Arnd Nusch
city: Ravensburg
country: Germany
facility: Studienzentrum Onkologie Ravensburg
city: Recklinghausen
country: Germany
facility: Praxis und Tagesklinik für Onkologie und Hämatologie
city: Regensburg
country: Germany
facility: Schwerpunktpraxis und Tagesklinik für Hämatologie und Onkologie
city: Remscheid
country: Germany
facility: Praxis und Tagesklinik für Onkologie und Hämatologie
city: Remscheid
country: Germany
facility: Onkologische Praxis Remscheid
city: Rheinbach
country: Germany
facility: Schwerpunktpraxis im Ärztehaus Rheinbach
city: Rheine
country: Germany
facility: Gemeinschaftspraxis für internistische Hämatologie und Onkologie
city: Rostock
country: Germany
facility: Praxis für Hämatologie und Internistische Onkologie
city: Rostock
country: Germany
facility: Klinikum Südstadt Rostock Innere Medizin III
city: Rüsselsheim
country: Germany
facility: GPR Gesundheits- und Pflegezentrum Rüsselsheim
city: Schorndorf
country: Germany
facility: Zentrum Ambulante Onkologie
city: Singen (Hohentwiel)
country: Germany
facility: Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
city: Soest
country: Germany
facility: MVZ Kloster Paradiese GbR
city: Stolberg
country: Germany
facility: Hämatologie - Onkologie - Stolberg
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart; Katharinenhospital Hämatologie, Onkologie und Palliativmedizin
city: Stuttgart
country: Germany
facility: MVZ Leuschnerstr.
city: Traunstein
country: Germany
facility: Kliniken Südostbayern - Klinikum Traunstein
city: Troisdorf
country: Germany
facility: Praxisnetzwerk Hämatologie / internistische Onkologie
city: Villingen-Schwenningen
country: Germany
facility: Onkologie Schwarzwald-Alb Dr. med. G. Köchling
city: Weinheim
country: Germany
facility: Praxen MVZ für Innere Medizin
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Wilhelmshaven
country: Germany
facility: Praxisgemeinschaft für Onkologie und Urologie
city: Worms
country: Germany
facility: Internistische Gemeinschaftspraxis,Hämatologie, Onkologie,Palliativmedizin
city: Würselen
country: Germany
facility: MVZ West GmbH Würselen Hämatologie-Onkologie
city: Würzburg
country: Germany
facility: Hämatologisch-Onkologische, Schwerpunktpraxis Würzburg GbR,Dres. med. R. Schlag & B. Schöttker
city: Zittau
country: Germany
facility: Praxis und Tagesklinik für Hämatologie/Onkologie
Study officials:
affiliation: Outpatient center for hematology and oncology, Freiburg, Germany
name: Norbert Marschner, MD
role: PRINCIPAL_INVESTIGATOR
References: