Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology
- Conditions
- Advanced Solid Tumors or Hematologic Malignancies
- Registration Number
- NCT04389541
- Lead Sponsor
- iOMEDICO AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 499
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate Maximum 5 years Proportion of patients with CR or PR as best response
- Secondary Outcome Measures
Name Time Method Duration of Response Maximum 5 years Time from documentation of tumor response to disease progression or death from any cause
Time to treatment failure Maximum 5 years Time from start of therapy to discontinuation of treatment for any reason, including progression, toxicity, and death
PFS ratio Maximum 5 years PFS ratio of targeted non-standard therapy and preceding treatment line
Patient and Disease Characteristics maximum 5 years Describe demographics, comorbidities and tumor type of patients not eligible for standard therapies.
Best overall response Maximum 5 years Proportion of patients with complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
Details on molecular diagnostics Maximum 5 years Frequency of type of molecular diagnostic testing performed, of single gene/protein tests, multigene panels or NGS in molecular diagnostics, of type (by panel size) of NGS library sequenced, of proteins and genes tested, of altered proteins and genes, if tested, of treatment recommendations given in molecular diagnostic reports, of implemented treatment recommendations given in molecular diagnostic reports, of the use of a molecular tumor board (MTB), of implementation of the treatment recommendation given by MTB and duration from molecular testing result to start of non-standard targeted treatment
Clinical decision making Maximum 5 years (once per targeted therapy) Frequency of answers rated with a Likert scale on patient's non-suitability for standard therapy options / choice of performed molecular diagnostics / choice of selected molecular target and targeted non-standard therapy / reasons for the selection of targeted non-standard therapy / primary goal of the non-standard targeted therapy / expected advantages of the non-standard targeted therapy and frequency of ESMO Scale of Clinical Actionability for molecular Targets (ESCAT) evidence levels
Evaluation of selected treatment approach assessed via project specific survey Maximum 5 years (once per completed targeted therapy) Frequency of pre-defined answers on therapy duration, effectiveness and overall benefit
Disease Control Rate Maximum 5 years Proportion of patients with CR, PR or SD as best response
Time to Response Maximum 5 years Time from start of treatment to the first objective tumor response (e.g., tumor shrinkage of ≥30%) observed for patients who achieved a CR or PR
Progression-free survival Maximum 5 years Time from start of treatment until disease progression or death
Overall Survival Maximum 5 years Time from start of treatment until death of any cause
Trial Locations
- Locations (94)
Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
🇩🇪Hamburg, Germany
Hämatologisch-Onkologische Praxis Altona (HOPA)
🇩🇪Hamburg, Germany
Klinikum Darmstadt, Onkologisches Studienzentrum
🇩🇪Darmstadt, Germany
Gemeinschaftspraxis Dr. Haytham Kamal und Dr. David C. Dorn
🇩🇪Hannover, Germany
Onkologische Schwerpunktpraxis im Medicinum
🇩🇪Hildesheim, Germany
Hämatologisch-Onkologische Schwerpunktpraxis Bad Liebenwerda
🇩🇪Bad Liebenwerda, Germany
MVZ am Klinikum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Studienzentrum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Evangelisches Waldkrankenhaus,Spandau,Innere Medizin I
🇩🇪Berlin, Germany
Onkologische Schwerpunktpraxis
🇩🇪Heidelberg, Germany
Klinikum Bayreuth; Klinik für Onkologie und Hämatologie
🇩🇪Bayreuth, Germany
Onkologisches Versorgungszentrum Friedrichshain
🇩🇪Berlin, Germany
Gemeinschaftspraxis für Onkologie und Hämatologie
🇩🇪Berlin, Germany
Klinikum Coburg Hämatologie, Onkologie
🇩🇪Coburg, Germany
Universitätsklinikum Frankfurt; Medizinische Klinik 1: Pneumologie, Gastroenterologie, Hepatologie
🇩🇪Frankfurt a.M., Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, München MVZ GmbH
🇩🇪Köln, Germany
Internisten am Markt
🇩🇪Köthen, Germany
Internistische Praxis und Tagesklinik
🇩🇪Neustadt i.S., Germany
Onkozentrum Dresden/Freiberg
🇩🇪Dresden, Germany
Studienbüro CHOP GmbH
🇩🇪Frankfurt a.M., Germany
MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
🇩🇪Berlin, Germany
Gemeinschaftspraxis Panagiotou/Minaei (GbR)
🇩🇪Garbsen, Germany
BAG / Onkologische Gemeinschaftspraxis
🇩🇪Dresden, Germany
Agaplesion Markus Krankenhaus
🇩🇪Frankfurt a.M., Germany
Universitätsklinikum Frankfurt; Medizinische Klinik 2, Hämatologie, Onkologie
🇩🇪Frankfurt a.M., Germany
MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie
🇩🇪Georgsmarienhütte, Germany
Gemeinschaftspraxis Dres. Schmitt und Eulenbruch
🇩🇪Gerlingen, Germany
OSP Göttingen Dres. Meyer / Ammon / Metz
🇩🇪Göttingen, Germany
Gemeinschaftspraxis für Innere Medizin, Hämatologie, Onkologie, Gastroenterologie
🇩🇪Halle (Saale), Germany
Klinikum Kassel, Klinik für Onkologie und Hämatologie
🇩🇪Kassel, Germany
MVZ Hämatologie und Onkologie Dr. Michael Neise & Dr. André Lollert
🇩🇪Krefeld, Germany
Brustzentrum Niederrhein im evangelischen Krankenhaus Bethesda
🇩🇪Mönchengladbach, Germany
Studiengesellschaft Hämato-Onkologie Hamburg Prof. Laack & Partner GbR
🇩🇪Hamburg, Germany
Cancer Center Zweiseenland GbR
🇩🇪Herrsching, Germany
Onkologie UnterEms Leer-Emden-Papenburg
🇩🇪Leer, Germany
Praxis für Hämatologie, Onkologie & Palliativmedizin
🇩🇪Mönchengladbach, Germany
MVZ für Blut- und Krebserkrankungen
🇩🇪Potsdam, Germany
Dr. Arnd Nusch
🇩🇪Ratingen, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
🇩🇪Lebach, Germany
MVZ Mitte am Johannisplatz
🇩🇪Leipzig, Germany
MVZ Onkologie GmbH am Elisabeth-Krankenhaus Rheydt
🇩🇪Mönchengladbach, Germany
Gemeinschaftspraxis für Hämatologie internistische Onkologie
🇩🇪Mülheim an der Ruhr, Germany
Medizinisches Zentrum für Hämatologie und Onkologie
🇩🇪München, Germany
Hämatologisch-onkologische Gemeinschaftspraxis
🇩🇪Münster, Germany
Friedrich-Ebert-Krankenhaus
🇩🇪Neumünster, Germany
Onkologie Offenburg Ambulantes Therapiezentrum für Hämatologie und Onkologie
🇩🇪Offenburg, Germany
Pius-Hospital Oldenburg Hämatologie, Onkologie
🇩🇪Oldenburg, Germany
Schwerpunktpraxis und Tagesklinik für Hämatologie und Onkologie
🇩🇪Regensburg, Germany
Schwerpunktpraxis im Ärztehaus Rheinbach
🇩🇪Rheinbach, Germany
Klinikum Stuttgart; Katharinenhospital Hämatologie, Onkologie und Palliativmedizin
🇩🇪Stuttgart, Germany
Studienzentrum Onkologie Ravensburg
🇩🇪Ravensburg, Germany
Praxis und Tagesklinik für Onkologie und Hämatologie
🇩🇪Remscheid, Germany
Gemeinschaftspraxis für internistische Hämatologie und Onkologie
🇩🇪Rheine, Germany
Praxis für Hämatologie und Internistische Onkologie
🇩🇪Rostock, Germany
Onkologische Praxis Remscheid
🇩🇪Remscheid, Germany
Praxisnetzwerk Hämatologie / internistische Onkologie
🇩🇪Troisdorf, Germany
Klinikum Südstadt Rostock Innere Medizin III
🇩🇪Rostock, Germany
GPR Gesundheits- und Pflegezentrum Rüsselsheim
🇩🇪Rüsselsheim, Germany
Zentrum Ambulante Onkologie
🇩🇪Schorndorf, Germany
MVZ Kloster Paradiese GbR
🇩🇪Soest, Germany
MVZ Leuschnerstr.
🇩🇪Stuttgart, Germany
Kliniken Südostbayern - Klinikum Traunstein
🇩🇪Traunstein, Germany
Onkologie Schwarzwald-Alb Dr. med. G. Köchling
🇩🇪Villingen-Schwenningen, Germany
Praxis und Tagesklinik für Hämatologie/Onkologie
🇩🇪Zittau, Germany
MVZ West GmbH Würselen Hämatologie-Onkologie
🇩🇪Würselen, Germany
Praxisgemeinschaft für Onkologie und Urologie
🇩🇪Wilhelmshaven, Germany
Praxen MVZ für Innere Medizin
🇩🇪Weinheim, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
🇩🇪Westerstede, Germany
Hämatologie - Onkologie - Stolberg
🇩🇪Stolberg, Germany
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gemeinnützige GmbH
🇩🇪Bamberg, Germany
Onkologische Schwerpunktpraxis Bamberg
🇩🇪Bamberg, Germany
Onkologisch-Hämatologische Schwerpunktpraxis
🇩🇪Bremen, Germany
Schwerpunktpraxis für Hämatologie und internistische Onkologie Coburg
🇩🇪Coburg, Germany
Onkologisches Zentrum Deggendorf
🇩🇪Deggendorf, Germany
Onkologische Gemeinschaftspraxis
🇩🇪Dresden, Germany
MVZ Onkologie und Hämatologie am Sana Krankenhaus Gerresheim
🇩🇪Düsseldorf, Germany
Praxis und Tagesklinik für gynäkologische Onkologie
🇩🇪Ebersberg, Germany
Praxis für interdisziplinäre Onkologie & Hämatologie
🇩🇪Freiburg, Germany
Überörtliche Berufsausübungsgemeinschaft, MVZ Onkologische Kooperation Harz
🇩🇪Goslar, Germany
MediProjekt GbR
🇩🇪Hannover, Germany
SLK Kliniken Heilbronn Klinik für Innere Medizin III
🇩🇪Heilbronn, Germany
Onkologische Schwerpunktpraxis Dres. Hansen & Reeb
🇩🇪Kaiserslautern, Germany
PIOH - Praxis Internistische Onkologie und Hämatologie
🇩🇪Köln, Germany
ÜBAG - MVZ Dr. Vehling-Kaiser GmbH
🇩🇪Landshut, Germany
Mannheimer Onkologie Praxis
🇩🇪Mannheim, Germany
Gemeinschaftspraxis für Hämatologie & Onkologie
🇩🇪Moers, Germany
TZN - Tumorzentrum Niederrhein GmbH
🇩🇪Neuss, Germany
MVZ Onko Medical GmbH Neustadt Innere, Med./Hämatologie-Onkologie
🇩🇪Neustadt Am Rübenberge, Germany
Onkologische Praxis Passau
🇩🇪Passau, Germany
Zentrum für Hämatologie und Onkologie MVZ GmbH
🇩🇪Porta Westfalica, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
🇩🇪Berlin, Germany
Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
🇩🇪Singen (Hohentwiel), Germany
Internistische Gemeinschaftspraxis,Hämatologie, Onkologie,Palliativmedizin
🇩🇪Worms, Germany
Hämatologisch-Onkologische, Schwerpunktpraxis Würzburg GbR,Dres. med. R. Schlag & B. Schöttker
🇩🇪Würzburg, Germany