Genomic Testing and Resulting Medical Decisions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer of Unknown Origin, Cancer Refractory, Cancer of Stomach, Cancer Head Neck, Cancer of Skin, Cancer, Lung, Cancer Colorectal, Cancer of Esophagus, Cancer, Bladder, Cancer, Uterus, Cancer Cervix, Cancer Liver, Cancer, Kidney, Cancer, Breast, Hematologic Neoplasms

Intervention / Treatment
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* Other: Genomic testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Genomic testing|Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of:molecular profiling methods | To describe types of:molecular profiling methods used in the Austrian registry centres | 3 years | 
| Types of cancer, for which comprehensive molecular profiling is used | To describe types of cancer, for which comprehensive molecular profiling is used | 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) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 3 years | 
| Outcome of treatment | To describe outcome of treatment in patients receiving therapy in concordance with the test result | 3 years |