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Advanced Solid Tumors or Hematologic MalignanciesINFINITYNCT04389541

Clinical Research Platform on Decision Making and Clinical Impact of Biomarker-Driven Precision Oncology

An observational study of Advanced Solid Tumors or Hematologic Malignancies, run by iOMEDICO AG at 97 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
499 participants
Where
97 sitesGermany
Study dates
17 Apr 2020to 30 Jun 2023
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

97 sites in 1 country.

97 sites in 1 country

Germany97 sites

  • MVZ am Klinikum Aschaffenburg

    Aschaffenburg, 63739

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739

  • Onkologische Schwerpunktpraxis

    Augsburg, 86152

  • Hämatologisch-Onkologische Schwerpunktpraxis Bad Liebenwerda

    Bad Liebenwerda, 04924

  • Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gemeinnützige GmbH

    Bamberg, 96049

  • Onkologische Schwerpunktpraxis Bamberg

    Bamberg, 96052

  • Klinikum Bayreuth; Klinik für Onkologie und Hämatologie

    Bayreuth, 95445

  • Onkologisches Versorgungszentrum Friedrichshain

    Berlin, 10407

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Gemeinschaftspraxis für Onkologie und Hämatologie

    Berlin, 12627

  • Evangelisches Waldkrankenhaus,Spandau,Innere Medizin I

    Berlin, 13589

  • MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim

    Berlin, 14195

  • Onkologisch-Hämatologische Schwerpunktpraxis

    Bremen, 28209

  • Klinikum Coburg Hämatologie, Onkologie

    Coburg, 96450

  • Schwerpunktpraxis für Hämatologie und internistische Onkologie Coburg

    Coburg, 96450

  • PIOH - Praxis Internistische Onkologie und Hämatologie

    Cologne, 50674

  • Gemeinschaftspraxis für Hämatologie und Onkologie, München MVZ GmbH

    Cologne, 51103

  • Klinikum Darmstadt, Onkologisches Studienzentrum

    Darmstadt, 64283

  • Onkologisches Zentrum Deggendorf

    Deggendorf, 94469

  • Onkozentrum Dresden/Freiberg

    Dresden, 01127

  • BAG / Onkologische Gemeinschaftspraxis

    Dresden, 01307

  • Onkologische Gemeinschaftspraxis

    Dresden, 01307

  • MVZ Onkologie und Hämatologie am Sana Krankenhaus Gerresheim

    Düsseldorf, 40625

  • Praxis und Tagesklinik für gynäkologische Onkologie

    Ebersberg, 85560

  • Studienbüro CHOP GmbH

    Frankfurt a.M., 60389

  • Agaplesion Markus Krankenhaus

    Frankfurt a.M., 60431

  • Universitätsklinikum Frankfurt; Medizinische Klinik 1: Pneumologie, Gastroenterologie, Hepatologie

    Frankfurt a.M., 60590

  • Universitätsklinikum Frankfurt; Medizinische Klinik 2, Hämatologie, Onkologie

    Frankfurt a.M., 60590

  • Praxis für interdisziplinäre Onkologie & Hämatologie

    Freiburg im Breisgau, 79110

  • Gemeinschaftspraxis Panagiotou/Minaei (GbR)

    Garbsen, 30823

  • MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie

    Georgsmarienhütte, 49124

  • Gemeinschaftspraxis Dres. Schmitt und Eulenbruch

    Gerlingen, 70839

  • Überörtliche Berufsausübungsgemeinschaft, MVZ Onkologische Kooperation Harz

    Goslar, 38642

  • OSP Göttingen Dres. Meyer / Ammon / Metz

    Göttingen, 37073

  • Gemeinschaftspraxis für Innere Medizin, Hämatologie, Onkologie, Gastroenterologie

    Halle, 06110

  • Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

    Hamburg, 20249

  • Studiengesellschaft Hämato-Onkologie Hamburg Prof. Laack & Partner GbR

    Hamburg, 20251

  • Hämatologisch-Onkologische Praxis Altona (HOPA)

    Hamburg, 22767

  • Onkologische Schwerpunktpraxis

    Hanover, 30161

  • MediProjekt GbR

    Hanover, 30171

  • Gemeinschaftspraxis Dr. Haytham Kamal und Dr. David C. Dorn

    Hanover, 30625

  • Onkologische Schwerpunktpraxis

    Heidelberg, 69115

  • SLK Kliniken Heilbronn Klinik für Innere Medizin III

    Heilbronn, 74078

  • Cancer Center Zweiseenland GbR

    Herrsching am Ammersee, 82211

  • Onkologische Schwerpunktpraxis im Medicinum

    Hildesheim, 31135

  • Onkologische Schwerpunktpraxis Dres. Hansen & Reeb

    Kaiserslautern, 67655

  • Klinikum Kassel, Klinik für Onkologie und Hämatologie

    Kassel, 34125

  • Internisten am Markt

    Köthen, 06366

  • MVZ Hämatologie und Onkologie Dr. Michael Neise & Dr. André Lollert

    Krefeld, 47805

  • ÜBAG - MVZ Dr. Vehling-Kaiser GmbH

    Landshut, 84036

  • Gemeinschaftspraxis für Hämatologie und Onkologie GbR

    Lebach, 66822

  • Onkologie UnterEms Leer-Emden-Papenburg

    Leer, 26789

  • MVZ Mitte am Johannisplatz

    Leipzig, 04103

  • Mannheimer Onkologie Praxis

    Mannheim, 68161

  • Gemeinschaftspraxis für Hämatologie & Onkologie

    Moers, 47441

  • Brustzentrum Niederrhein im evangelischen Krankenhaus Bethesda

    Mönchengladbach, 41061

  • Praxis für Hämatologie, Onkologie & Palliativmedizin

    Mönchengladbach, 41066

  • MVZ Onkologie GmbH am Elisabeth-Krankenhaus Rheydt

    Mönchengladbach, 41239

  • Gemeinschaftspraxis für Hämatologie internistische Onkologie

    Mülheim, 45468

  • Medizinisches Zentrum für Hämatologie und Onkologie

    München, 80639

  • Hämatologisch-onkologische Gemeinschaftspraxis

    Münster, 48149

  • Friedrich-Ebert-Krankenhaus

    Neumünster, 24534

  • TZN - Tumorzentrum Niederrhein GmbH

    Neuss, 41462

  • MVZ Onko Medical GmbH Neustadt Innere, Med./Hämatologie-Onkologie

    Neustadt am Rübenberge, 31535

  • Internistische Praxis und Tagesklinik

    Neustadt i.S., 01844

  • Onkologie Offenburg Ambulantes Therapiezentrum für Hämatologie und Onkologie

    Offenburg, 77654

  • Pius-Hospital Oldenburg Hämatologie, Onkologie

    Oldenburg, 26121

  • Onkologische Praxis Passau

    Passau, 94036

  • Zentrum für Hämatologie und Onkologie MVZ GmbH

    Porta Westfalica, 32457

  • MVZ für Blut- und Krebserkrankungen

    Potsdam, 14467

  • Dr. Arnd Nusch

    Ratingen, 40883

  • Studienzentrum Onkologie Ravensburg

    Ravensburg, 88212

  • Praxis und Tagesklinik für Onkologie und Hämatologie

    Recklinghausen, 45659

  • Schwerpunktpraxis und Tagesklinik für Hämatologie und Onkologie

    Regensburg, 93053

  • Praxis und Tagesklinik für Onkologie und Hämatologie

    Remscheid, 42853

  • Onkologische Praxis Remscheid

    Remscheid, 42859

  • Schwerpunktpraxis im Ärztehaus Rheinbach

    Rheinbach, 53359

  • Gemeinschaftspraxis für internistische Hämatologie und Onkologie

    Rheine, 48431

  • Praxis für Hämatologie und Internistische Onkologie

    Rostock, 18057

  • Klinikum Südstadt Rostock Innere Medizin III

    Rostock, 18059

  • GPR Gesundheits- und Pflegezentrum Rüsselsheim

    Rüsselsheim am Main, 65428

  • Zentrum Ambulante Onkologie

    Schorndorf, 73614

  • Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie

    Singen (Hohentwiel), 78224

  • MVZ Kloster Paradiese GbR

    Soest, 59494

  • Hämatologie - Onkologie - Stolberg

    Stolberg, 52222

  • Klinikum Stuttgart; Katharinenhospital Hämatologie, Onkologie und Palliativmedizin

    Stuttgart, 70174

  • MVZ Leuschnerstr.

    Stuttgart, 70174

  • Kliniken Südostbayern - Klinikum Traunstein

    Traunstein, 83278

  • Praxisnetzwerk Hämatologie / internistische Onkologie

    Troisdorf, 53840

  • Onkologie Schwarzwald-Alb Dr. med. G. Köchling

    Villingen-Schwenningen, 78052

  • Praxen MVZ für Innere Medizin

    Weinheim, 69469

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Westerstede, 26655

  • Praxisgemeinschaft für Onkologie und Urologie

    Wilhelmshaven, 26389

  • Internistische Gemeinschaftspraxis,Hämatologie, Onkologie,Palliativmedizin

    Worms, 67547

  • MVZ West GmbH Würselen Hämatologie-Onkologie

    Würselen, 52146

  • Hämatologisch-Onkologische, Schwerpunktpraxis Würzburg GbR,Dres. med. R. Schlag & B. Schöttker

    Würzburg, 97080

  • Praxis und Tagesklinik für Hämatologie/Onkologie

    Zittau, 02763

Other trials in Germany

About this study

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.

Medical subject headings
Hematologic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Proportion of patients with CR or PR as best response

    Measured: Maximum 5 years

Secondary outcomes (12)

  1. Patient and Disease Characteristics

    Describe demographics, comorbidities and tumor type of patients not eligible for standard therapies.

    Measured: maximum 5 years

  2. Details on molecular diagnostics

    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

    Measured: Maximum 5 years

  3. Clinical decision making

    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

    Measured: Maximum 5 years (once per targeted therapy)

  4. Evaluation of selected treatment approach assessed via project specific survey

    Frequency of pre-defined answers on therapy duration, effectiveness and overall benefit

    Measured: Maximum 5 years (once per completed targeted therapy)

  5. Best overall response

    Proportion of patients with complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)

    Measured: Maximum 5 years

  6. Disease Control Rate

    Proportion of patients with CR, PR or SD as best response

    Measured: Maximum 5 years

  7. Time to Response

    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

    Measured: Maximum 5 years

  8. Duration of Response

    Time from documentation of tumor response to disease progression or death from any cause

    Measured: Maximum 5 years

  9. Time to treatment failure

    Time from start of therapy to discontinuation of treatment for any reason, including progression, toxicity, and death

    Measured: Maximum 5 years

  10. Progression-free survival

    Time from start of treatment until disease progression or death

    Measured: Maximum 5 years

  11. PFS ratio

    PFS ratio of targeted non-standard therapy and preceding treatment line

    Measured: Maximum 5 years

  12. Overall Survival

    Time from start of treatment until death of any cause

    Measured: Maximum 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study start17 Apr 2020
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
499 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04389541
Sponsor's protocol ID
IOM-050408
Acronym
INFINITY
Status last verified
Aug 2023
First submitted
17 Apr 2020
Last updated
14 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37312086

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Solid Tumors or Hematologic Malignancies, run by iOMEDICO AG at 97 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: Maximum 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04389541, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

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