Genomic Testing and Resulting Medical Decisions

The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification

Sponsors

Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborator: Roche Pharma AG

Source Arbeitsgemeinschaft medikamentoese Tumortherapie
Brief Summary

There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.

Detailed Description

In the situation of enormous possible beneficial options for patients, health care systems, researchers and companies and the simultaneously present high number of uncertainties, the establishment of an independent registry for patients undergoing any type of comprehensive genomic profiling offers many advantages. In particular, an overview of the speed of development, the "market penetration", the use of the technology in specific indications (tumor types, stages and in specific situations of unresponsiveness to certain drugs), the frequency by which treatment decisions will definitely follow the result of comprehensive genomic profiling and the reasons for this, the treatment outcome of such patients, the platform technologies applied (in-house (which types), vs. commercial) and the development of these parameters over time and in relation to the development of novel drugs will be analyzed. The registry proposes to cover the time period from the years 2016 to 2019, which will allow for assessment of both the current and emerging landscape of genomic/molecular testing practice in Austria and effect of molecular profiling on patient care and outcome.

Overall Status Recruiting
Start Date 2017-03-30
Completion Date 2021-12-01
Primary Completion Date 2021-12-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Types of:molecular profiling methods 3 years
Types of cancer, for which comprehensive molecular profiling is used 3 years
Timing of molecular profiling 3 years
Secondary Outcome
Measure Time Frame
Number of patients with mutations identified 3 years
Quality standards 3 years
Treatment decisions 3 years
Outcome of treatment 3 years
Enrollment 500
Condition
Intervention

Intervention Type: Other

Intervention Name: Genomic testing

Description: Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice

Eligibility

Sampling Method:

Probability Sample

Criteria:

Inclusion Criteria: This registry will include cancer patients for which broad genomic profiling is indicated as assessed by the medical need and as deemed appropriate by the physician, for example - cancer with high mutational load and suspicion of regular or frequent formation of neoantigens - skin, lung, stomach, esophagus, colorectum, bladder, uterus, cervix, liver, head and neck, kidney, breast - lymphoma B-cell - any other neoplastic disease where molecular targeting is performed but treatment fails - cancer of unknown primary origin (CUP) - planned or already carried out comprehensive genomic testing as of Jan 1, 2016 note: this registry will not initially register patients who are tested for only 1-5 mutations by conventional means, but patients undergoing genomic profiling based on NGS) - a patient´s signed informed consent - Patients ≥ 18 years of age Exclusion Criteria: - Due to the non-interventional design of the registry there are no specific exclusion criteria.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Richard Greil, MD Principal Investigator IIIrd Medical Department, Private Medical University Hospital Salzburg
Overall Contact

Last Name: Richard Greil, MD

Phone: +43577255

Phone Ext.: 25801

Email: [email protected]

Location
Facility: Status: Contact:
Innere Medizin II, LKH Feldkirch | Feldkirch, 6807, Austria Recruiting Holger Rumpold, MD
Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie | Graz, A-8036, Austria Recruiting Herbert Stöger, MD
Universitätsklinikum Krems | Krems an der Donau, 6500, Austria Recruiting Martin Pecherstorfer, MD
BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie | Linz, A-4020, Austria Recruiting Andreas Petzer, MD
IIIrd Medical Department, Private Medical University Hospital Salzburg | Salzburg, 5020, Austria Recruiting Richard Greil, MD
St. Vinzenz Krankenhaus Betriebs GmbH | Zams, 6511, Austria Recruiting Edward Wöll, MD
Location Countries

Austria

Verification Date

2021-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Other

Time Perspective: Other

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