Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology
INFINITY
1 other identifier
observational
499
1 country
97
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2020
CompletedStudy Start
First participant enrolled
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedAugust 14, 2023
August 1, 2023
3.2 years
April 17, 2020
August 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate
Proportion of patients with CR or PR as best response
Maximum 5 years
Secondary Outcomes (12)
Patient and Disease Characteristics
maximum 5 years
Details on molecular diagnostics
Maximum 5 years
Clinical decision making
Maximum 5 years (once per targeted therapy)
Evaluation of selected treatment approach assessed via project specific survey
Maximum 5 years (once per completed targeted therapy)
Best overall response
Maximum 5 years
- +7 more secondary outcomes
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iOMEDICO AGlead
- Bristol-Myers Squibbcollaborator
- Roche Pharma AGcollaborator
Study Sites (97)
MVZ am Klinikum Aschaffenburg
Aschaffenburg, 63739, Germany
Studienzentrum Aschaffenburg
Aschaffenburg, 63739, Germany
Onkologische Schwerpunktpraxis
Augsburg, 86152, Germany
Hämatologisch-Onkologische Schwerpunktpraxis Bad Liebenwerda
Bad Liebenwerda, 04924, Germany
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gemeinnützige GmbH
Bamberg, 96049, Germany
Onkologische Schwerpunktpraxis Bamberg
Bamberg, 96052, Germany
Klinikum Bayreuth; Klinik für Onkologie und Hämatologie
Bayreuth, 95445, Germany
Onkologisches Versorgungszentrum Friedrichshain
Berlin, 10407, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, 10707, Germany
Gemeinschaftspraxis für Onkologie und Hämatologie
Berlin, 12627, Germany
Evangelisches Waldkrankenhaus,Spandau,Innere Medizin I
Berlin, 13589, Germany
MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, 14195, Germany
Onkologisch-Hämatologische Schwerpunktpraxis
Bremen, 28209, Germany
Klinikum Coburg Hämatologie, Onkologie
Coburg, 96450, Germany
Schwerpunktpraxis für Hämatologie und internistische Onkologie Coburg
Coburg, 96450, Germany
PIOH - Praxis Internistische Onkologie und Hämatologie
Cologne, 50674, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, München MVZ GmbH
Cologne, 51103, Germany
Klinikum Darmstadt, Onkologisches Studienzentrum
Darmstadt, 64283, Germany
Onkologisches Zentrum Deggendorf
Deggendorf, 94469, Germany
Onkozentrum Dresden/Freiberg
Dresden, 01127, Germany
BAG / Onkologische Gemeinschaftspraxis
Dresden, 01307, Germany
Onkologische Gemeinschaftspraxis
Dresden, 01307, Germany
MVZ Onkologie und Hämatologie am Sana Krankenhaus Gerresheim
Düsseldorf, 40625, Germany
Praxis und Tagesklinik für gynäkologische Onkologie
Ebersberg, 85560, Germany
Studienbüro CHOP GmbH
Frankfurt a.M., 60389, Germany
Agaplesion Markus Krankenhaus
Frankfurt a.M., 60431, Germany
Universitätsklinikum Frankfurt; Medizinische Klinik 1: Pneumologie, Gastroenterologie, Hepatologie
Frankfurt a.M., 60590, Germany
Universitätsklinikum Frankfurt; Medizinische Klinik 2, Hämatologie, Onkologie
Frankfurt a.M., 60590, Germany
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, 79110, Germany
Gemeinschaftspraxis Panagiotou/Minaei (GbR)
Garbsen, 30823, Germany
MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie
Georgsmarienhütte, 49124, Germany
Gemeinschaftspraxis Dres. Schmitt und Eulenbruch
Gerlingen, 70839, Germany
Überörtliche Berufsausübungsgemeinschaft, MVZ Onkologische Kooperation Harz
Goslar, 38642, Germany
OSP Göttingen Dres. Meyer / Ammon / Metz
Göttingen, 37073, Germany
Gemeinschaftspraxis für Innere Medizin, Hämatologie, Onkologie, Gastroenterologie
Halle, 06110, Germany
Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
Hamburg, 20249, Germany
Studiengesellschaft Hämato-Onkologie Hamburg Prof. Laack & Partner GbR
Hamburg, 20251, Germany
Hämatologisch-Onkologische Praxis Altona (HOPA)
Hamburg, 22767, Germany
Onkologische Schwerpunktpraxis
Hanover, 30161, Germany
MediProjekt GbR
Hanover, 30171, Germany
Gemeinschaftspraxis Dr. Haytham Kamal und Dr. David C. Dorn
Hanover, 30625, Germany
Onkologische Schwerpunktpraxis
Heidelberg, 69115, Germany
SLK Kliniken Heilbronn Klinik für Innere Medizin III
Heilbronn, 74078, Germany
Cancer Center Zweiseenland GbR
Herrsching am Ammersee, 82211, Germany
Onkologische Schwerpunktpraxis im Medicinum
Hildesheim, 31135, Germany
Onkologische Schwerpunktpraxis Dres. Hansen & Reeb
Kaiserslautern, 67655, Germany
Klinikum Kassel, Klinik für Onkologie und Hämatologie
Kassel, 34125, Germany
Internisten am Markt
Köthen, 06366, Germany
MVZ Hämatologie und Onkologie Dr. Michael Neise & Dr. André Lollert
Krefeld, 47805, Germany
ÜBAG - MVZ Dr. Vehling-Kaiser GmbH
Landshut, 84036, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
Lebach, 66822, Germany
Onkologie UnterEms Leer-Emden-Papenburg
Leer, 26789, Germany
MVZ Mitte am Johannisplatz
Leipzig, 04103, Germany
Mannheimer Onkologie Praxis
Mannheim, 68161, Germany
Gemeinschaftspraxis für Hämatologie & Onkologie
Moers, 47441, Germany
Brustzentrum Niederrhein im evangelischen Krankenhaus Bethesda
Mönchengladbach, 41061, Germany
Praxis für Hämatologie, Onkologie & Palliativmedizin
Mönchengladbach, 41066, Germany
MVZ Onkologie GmbH am Elisabeth-Krankenhaus Rheydt
Mönchengladbach, 41239, Germany
Gemeinschaftspraxis für Hämatologie internistische Onkologie
Mülheim, 45468, Germany
Medizinisches Zentrum für Hämatologie und Onkologie
München, 80639, Germany
Hämatologisch-onkologische Gemeinschaftspraxis
Münster, 48149, Germany
Friedrich-Ebert-Krankenhaus
Neumünster, 24534, Germany
TZN - Tumorzentrum Niederrhein GmbH
Neuss, 41462, Germany
MVZ Onko Medical GmbH Neustadt Innere, Med./Hämatologie-Onkologie
Neustadt am Rübenberge, 31535, Germany
Internistische Praxis und Tagesklinik
Neustadt i.S., 01844, Germany
Onkologie Offenburg Ambulantes Therapiezentrum für Hämatologie und Onkologie
Offenburg, 77654, Germany
Pius-Hospital Oldenburg Hämatologie, Onkologie
Oldenburg, 26121, Germany
Onkologische Praxis Passau
Passau, 94036, Germany
Zentrum für Hämatologie und Onkologie MVZ GmbH
Porta Westfalica, 32457, Germany
MVZ für Blut- und Krebserkrankungen
Potsdam, 14467, Germany
Dr. Arnd Nusch
Ratingen, 40883, Germany
Studienzentrum Onkologie Ravensburg
Ravensburg, 88212, Germany
Praxis und Tagesklinik für Onkologie und Hämatologie
Recklinghausen, 45659, Germany
Schwerpunktpraxis und Tagesklinik für Hämatologie und Onkologie
Regensburg, 93053, Germany
Praxis und Tagesklinik für Onkologie und Hämatologie
Remscheid, 42853, Germany
Onkologische Praxis Remscheid
Remscheid, 42859, Germany
Schwerpunktpraxis im Ärztehaus Rheinbach
Rheinbach, 53359, Germany
Gemeinschaftspraxis für internistische Hämatologie und Onkologie
Rheine, 48431, Germany
Praxis für Hämatologie und Internistische Onkologie
Rostock, 18057, Germany
Klinikum Südstadt Rostock Innere Medizin III
Rostock, 18059, Germany
GPR Gesundheits- und Pflegezentrum Rüsselsheim
Rüsselsheim am Main, 65428, Germany
Zentrum Ambulante Onkologie
Schorndorf, 73614, Germany
Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
Singen (Hohentwiel), 78224, Germany
MVZ Kloster Paradiese GbR
Soest, 59494, Germany
Hämatologie - Onkologie - Stolberg
Stolberg, 52222, Germany
Klinikum Stuttgart; Katharinenhospital Hämatologie, Onkologie und Palliativmedizin
Stuttgart, 70174, Germany
MVZ Leuschnerstr.
Stuttgart, 70174, Germany
Kliniken Südostbayern - Klinikum Traunstein
Traunstein, 83278, Germany
Praxisnetzwerk Hämatologie / internistische Onkologie
Troisdorf, 53840, Germany
Onkologie Schwarzwald-Alb Dr. med. G. Köchling
Villingen-Schwenningen, 78052, Germany
Praxen MVZ für Innere Medizin
Weinheim, 69469, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Westerstede, 26655, Germany
Praxisgemeinschaft für Onkologie und Urologie
Wilhelmshaven, 26389, Germany
Internistische Gemeinschaftspraxis,Hämatologie, Onkologie,Palliativmedizin
Worms, 67547, Germany
MVZ West GmbH Würselen Hämatologie-Onkologie
Würselen, 52146, Germany
Hämatologisch-Onkologische, Schwerpunktpraxis Würzburg GbR,Dres. med. R. Schlag & B. Schöttker
Würzburg, 97080, Germany
Praxis und Tagesklinik für Hämatologie/Onkologie
Zittau, 02763, Germany
Related Publications (1)
Martens UM, Schroder J, Bengsch F, Sellmann L, Busies S, Frank-Gleich S, Zaiss M, Decker T, Schneeweiss A, Schuler M, Grebhardt S, Zacharias S, Marschner N, Kasenda B, Potthoff K, Vannier C. The INFINITY study protocol: a retrospective cohort study on decision making and clinical impact of biomarker-driven precision oncology in routine clinical practice. BMC Cancer. 2023 Jun 13;23(1):543. doi: 10.1186/s12885-023-11046-3.
PMID: 37312086DERIVED
Biospecimen
Tissue samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norbert Marschner, MD
Outpatient center for hematology and oncology, Freiburg, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2020
First Posted
May 15, 2020
Study Start
April 17, 2020
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share