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

August 11, 2023 updated by: iOMEDICO AG
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
499

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Aschaffenburg, Germany, 63739
        • Studienzentrum Aschaffenburg
      • Aschaffenburg, Germany, 63739
        • MVZ am Klinikum Aschaffenburg
      • Augsburg, Germany, 86152
        • Onkologische Schwerpunktpraxis
      • Bad Liebenwerda, Germany, 04924
        • Hämatologisch-Onkologische Schwerpunktpraxis Bad Liebenwerda
      • Bamberg, Germany, 96049
        • Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gemeinnützige GmbH
      • Bamberg, Germany, 96052
        • Onkologische Schwerpunktpraxis Bamberg
      • Bayreuth, Germany, 95445
        • Klinikum Bayreuth; Klinik für Onkologie und Hämatologie
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis Kurfürstendamm
      • Berlin, Germany, 14195
        • MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
      • Berlin, Germany, 10407
        • Onkologisches Versorgungszentrum Friedrichshain
      • Berlin, Germany, 12627
        • Gemeinschaftspraxis für Onkologie und Hämatologie
      • Berlin, Germany, 13589
        • Evangelisches Waldkrankenhaus,Spandau,Innere Medizin I
      • Bremen, Germany, 28209
        • Onkologisch-Hämatologische Schwerpunktpraxis
      • Coburg, Germany, 96450
        • Klinikum Coburg Hämatologie, Onkologie
      • Coburg, Germany, 96450
        • Schwerpunktpraxis für Hämatologie und internistische Onkologie Coburg
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt, Onkologisches Studienzentrum
      • Deggendorf, Germany, 94469
        • Onkologisches Zentrum Deggendorf
      • Dresden, Germany, 01307
        • BAG / Onkologische Gemeinschaftspraxis
      • Dresden, Germany, 01127
        • Onkozentrum Dresden/Freiberg
      • Dresden, Germany, 01307
        • Onkologische Gemeinschaftspraxis
      • Düsseldorf, Germany, 40625
        • MVZ Onkologie und Hämatologie am Sana Krankenhaus Gerresheim
      • Ebersberg, Germany, 85560
        • Praxis und Tagesklinik für gynäkologische Onkologie
      • Frankfurt a.M., Germany, 60389
        • Studienbüro CHOP GmbH
      • Frankfurt a.M., Germany, 60431
        • Agaplesion Markus Krankenhaus
      • Frankfurt a.M., Germany, 60590
        • Universitätsklinikum Frankfurt; Medizinische Klinik 1: Pneumologie, Gastroenterologie, Hepatologie
      • Frankfurt a.M., Germany, 60590
        • Universitätsklinikum Frankfurt; Medizinische Klinik 2, Hämatologie, Onkologie
      • Freiburg, Germany, 79110
        • Praxis für interdisziplinäre Onkologie & Hämatologie
      • Garbsen, Germany, 30823
        • Gemeinschaftspraxis Panagiotou/Minaei (GbR)
      • Georgsmarienhütte, Germany, 49124
        • MVZ II der Niels Stensen Kliniken Onkologie u. Hämatologie
      • Gerlingen, Germany, 70839
        • Gemeinschaftspraxis Dres. Schmitt und Eulenbruch
      • Goslar, Germany, 38642
        • Überörtliche Berufsausübungsgemeinschaft, MVZ Onkologische Kooperation Harz
      • Göttingen, Germany, 37073
        • OSP Göttingen Dres. Meyer / Ammon / Metz
      • Halle (Saale), Germany, 06110
        • Gemeinschaftspraxis für Innere Medizin, Hämatologie, Onkologie, Gastroenterologie
      • Hamburg, Germany, 20249
        • Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
      • Hamburg, Germany, 20251
        • Studiengesellschaft Hämato-Onkologie Hamburg Prof. Laack & Partner GbR
      • Hamburg, Germany, 22767
        • Hämatologisch-onkologische Praxis Altona (HOPA)
      • Hannover, Germany, 30171
        • MediProjekt GBR
      • Hannover, Germany, 30161
        • Onkologische Schwerpunktpraxis
      • Hannover, Germany, 30625
        • Gemeinschaftspraxis Dr. Haytham Kamal und Dr. David C. Dorn
      • Heidelberg, Germany, 69115
        • Onkologische Schwerpunktpraxis
      • Heilbronn, Germany, 74078
        • SLK Kliniken Heilbronn Klinik für Innere Medizin III
      • Herrsching, Germany, 82211
        • cancer Center Zweiseenland GbR
      • Hildesheim, Germany, 31135
        • Onkologische Schwerpunktpraxis im Medicinum
      • Kaiserslautern, Germany, 67655
        • Onkologische Schwerpunktpraxis Dres. Hansen & Reeb
      • Kassel, Germany, 34125
        • Klinikum Kassel, Klinik für Onkologie und Hämatologie
      • Krefeld, Germany, 47805
        • MVZ Hämatologie und Onkologie Dr. Michael Neise & Dr. André Lollert
      • Köln, Germany, 50674
        • PIOH - Praxis Internistische Onkologie und Hämatologie
      • Köln, Germany, 51103
        • Gemeinschaftspraxis für Hämatologie und Onkologie, München MVZ GmbH
      • Köthen, Germany, 06366
        • Internisten am Markt
      • Landshut, Germany, 84036
        • ÜBAG - MVZ Dr. Vehling-Kaiser GmbH
      • Lebach, Germany, 66822
        • Gemeinschaftspraxis für Hämatologie und Onkologie GbR
      • Leer, Germany, 26789
        • Onkologie UnterEms Leer-Emden-Papenburg
      • Leipzig, Germany, 04103
        • MVZ Mitte Am Johannisplatz
      • Mannheim, Germany, 68161
        • Mannheimer Onkologie Praxis
      • Moers, Germany, 47441
        • Gemeinschaftspraxis für Hämatologie & Onkologie
      • Mönchengladbach, Germany, 41061
        • Brustzentrum Niederrhein im evangelischen Krankenhaus Bethesda
      • Mönchengladbach, Germany, 41066
        • Praxis für Hämatologie, Onkologie & Palliativmedizin
      • Mönchengladbach, Germany, 41239
        • MVZ Onkologie GmbH am Elisabeth-Krankenhaus Rheydt
      • Mülheim an der Ruhr, Germany, 45468
        • Gemeinschaftspraxis für Hämatologie internistische Onkologie
      • München, Germany, 80639
        • Medizinisches Zentrum für Hämatologie und Onkologie
      • Münster, Germany, 48149
        • Hämatologisch-Onkologische Gemeinschaftspraxis
      • Neumünster, Germany, 24534
        • Friedrich-Ebert-Krankenhaus
      • Neuss, Germany, 41462
        • TZN - Tumorzentrum Niederrhein GmbH
      • Neustadt Am Rübenberge, Germany, 31535
        • MVZ Onko Medical GmbH Neustadt Innere, Med./Hämatologie-Onkologie
      • Neustadt i.S., Germany, 01844
        • Internistische Praxis und Tagesklinik
      • Offenburg, Germany, 77654
        • Onkologie Offenburg Ambulantes Therapiezentrum für Hämatologie und Onkologie
      • Oldenburg, Germany, 26121
        • Pius-Hospital Oldenburg Hämatologie, Onkologie
      • Passau, Germany, 94036
        • Onkologische Praxis Passau
      • Porta Westfalica, Germany, 32457
        • Zentrum für Hämatologie und Onkologie MVZ GmbH
      • Potsdam, Germany, 14467
        • MVZ für Blut- und Krebserkrankungen
      • Ratingen, Germany, 40883
        • Dr. Arnd Nusch
      • Ravensburg, Germany, 88212
        • Studienzentrum Onkologie Ravensburg
      • Recklinghausen, Germany, 45659
        • Praxis und Tagesklinik für Onkologie und Hämatologie
      • Regensburg, Germany, 93053
        • Schwerpunktpraxis und Tagesklinik für Hämatologie und Onkologie
      • Remscheid, Germany, 42853
        • Praxis und Tagesklinik für Onkologie und Hämatologie
      • Remscheid, Germany, 42859
        • Onkologische Praxis Remscheid
      • Rheinbach, Germany, 53359
        • Schwerpunktpraxis im Ärztehaus Rheinbach
      • Rheine, Germany, 48431
        • Gemeinschaftspraxis für internistische Hämatologie und Onkologie
      • Rostock, Germany, 18057
        • Praxis für Hämatologie und internistische Onkologie
      • Rostock, Germany, 18059
        • Klinikum Südstadt Rostock Innere Medizin III
      • Rüsselsheim, Germany, 65428
        • GPR Gesundheits- und Pflegezentrum Rüsselsheim
      • Schorndorf, Germany, 73614
        • Zentrum Ambulante Onkologie
      • Singen (Hohentwiel), Germany, 78224
        • Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
      • Soest, Germany, 59494
        • MVZ Kloster Paradiese GbR
      • Stolberg, Germany, 52222
        • Hämatologie - Onkologie - Stolberg
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart; Katharinenhospital Hämatologie, Onkologie und Palliativmedizin
      • Stuttgart, Germany, 70174
        • MVZ Leuschnerstr.
      • Traunstein, Germany, 83278
        • Kliniken Südostbayern - Klinikum Traunstein
      • Troisdorf, Germany, 53840
        • Praxisnetzwerk Hämatologie / internistische Onkologie
      • Villingen-Schwenningen, Germany, 78052
        • Onkologie Schwarzwald-Alb Dr. med. G. Köchling
      • Weinheim, Germany, 69469
        • Praxen MVZ für Innere Medizin
      • Westerstede, Germany, 26655
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Wilhelmshaven, Germany, 26389
        • Praxisgemeinschaft für Onkologie und Urologie
      • Worms, Germany, 67547
        • Internistische Gemeinschaftspraxis,Hämatologie, Onkologie,Palliativmedizin
      • Würselen, Germany, 52146
        • MVZ West GmbH Würselen Hämatologie-Onkologie
      • Würzburg, Germany, 97080
        • Hämatologisch-Onkologische, Schwerpunktpraxis Würzburg GbR,Dres. med. R. Schlag & B. Schöttker
      • Zittau, Germany, 02763
        • Praxis und Tagesklinik für Hämatologie/Onkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: Maximum 5 years
Proportion of patients with CR or PR as best response
Maximum 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient and Disease Characteristics
Time Frame: maximum 5 years
Describe demographics, comorbidities and tumor type of patients not eligible for standard therapies.
maximum 5 years
Details on molecular diagnostics
Time Frame: 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
Maximum 5 years
Clinical decision making
Time Frame: 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
Maximum 5 years (once per targeted therapy)
Evaluation of selected treatment approach assessed via project specific survey
Time Frame: Maximum 5 years (once per completed targeted therapy)
Frequency of pre-defined answers on therapy duration, effectiveness and overall benefit
Maximum 5 years (once per completed targeted therapy)
Best overall response
Time Frame: Maximum 5 years
Proportion of patients with complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
Maximum 5 years
Disease Control Rate
Time Frame: Maximum 5 years
Proportion of patients with CR, PR or SD as best response
Maximum 5 years
Time to Response
Time Frame: 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
Maximum 5 years
Duration of Response
Time Frame: Maximum 5 years
Time from documentation of tumor response to disease progression or death from any cause
Maximum 5 years
Time to treatment failure
Time Frame: Maximum 5 years
Time from start of therapy to discontinuation of treatment for any reason, including progression, toxicity, and death
Maximum 5 years
Progression-free survival
Time Frame: Maximum 5 years
Time from start of treatment until disease progression or death
Maximum 5 years
PFS ratio
Time Frame: Maximum 5 years
PFS ratio of targeted non-standard therapy and preceding treatment line
Maximum 5 years
Overall Survival
Time Frame: Maximum 5 years
Time from start of treatment until death of any cause
Maximum 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
iOMEDICO AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb
Roche Pharma AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Norbert Marschner, MD, Outpatient center for hematology and oncology, Freiburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IOM-050408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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