Genomic Testing and Resulting Medical Decisions

Arbeitsgemeinschaft medikamentoese Tumortherapie1,500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Cancer of Unknown Origin Cancer Refractory Cancer of Stomach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

IIIrd Medical Department, Private Medical University Hospital Salzburg

Salzburg, Salzburg, Austria

Innere Medizin II, LKH Feldkirch

Feldkirch, Austria

Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie

Graz, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Universitätsklinikum Krems

Krems, Austria

BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie

Linz, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

Medizinische Universität Wien

Vienna, Austria

Salzkammergut-Klinikum Vöcklabruck

Vöcklabruck, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Austria

...and 1 more locations

Outcomes

Primary Outcomes

Types of:molecular profiling methods

To describe types of:molecular profiling methods used in the Austrian registry centres

Time frame: 3 years

Types of cancer, for which comprehensive molecular profiling is used

To describe types of cancer, for which comprehensive molecular profiling is used

Time frame: 3 years

Timing of molecular profiling

To describe the timing of molecular profiling in relation to stage of the disease (e.g. at diagnosis, after surgery, radiation therapy, after first/second/third/late line)

Time frame: 3 years

Secondary Outcomes

Number of patients with mutations identified

To describe targets identified: * number of patients with at least one mutation identified * number of patients with at least one druggable target identified * number of patients with more than one druggable targets identified * number of druggable targets per cancer type

Time frame: 3 years

Quality standards

To describe tests used and quality standards: * to compare results of NGS based molecular test systems with single marker tests or small gene panel tests * quality standards of the test methods used (TAT, certification status) * to evaluate development of methods used over time * usage of commercial testing vs. in-house testing, platforms used, and number of genes as well as gene size analyzed (eg whole exome with or without selected intron sequencing vs. hot spot exome sequencing)

Time frame: 3 years

Treatment decisions

To describe treatment decisions: * frequency by which treatment decision follows the result of NGS testing * frequency with druggable targets with available on-label therapy option * treatment decisions in the presence of more than one druggable target

Time frame: 3 years

Outcome of treatment

To describe outcome of treatment in patients receiving therapy in concordance with the test result

Time frame: 3 years

Genomic Testing and Resulting Medical Decisions

Overview

Conditions

Interventions

Eligibility

Locations (11)

Outcomes

Primary Outcomes

Secondary Outcomes