Genomic Testing and Resulting Medical Decisions

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie (Other)

Overall Status

Recruiting

CT.gov ID

NCT03301493

Collaborator

Roche Pharma AG (Industry), AstraZeneca (Industry)

1,000

Enrollment

Locations

68.1

Anticipated Duration (Months)

90.9

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Genomic testing

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Mar 30, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Types of:molecular profiling methods [3 years]
To describe types of:molecular profiling methods used in the Austrian registry centres
Types of cancer, for which comprehensive molecular profiling is used [3 years]
To describe types of cancer, for which comprehensive molecular profiling is used
Timing of molecular profiling [3 years]
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)

Secondary Outcome Measures

Number of patients with mutations identified [3 years]
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
Quality standards [3 years]
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)
Treatment decisions [3 years]
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
Outcome of treatment [3 years]
To describe outcome of treatment in patients receiving therapy in concordance with the test result

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Innere Medizin II, LKH Feldkirch	Feldkirch	Austria	6807
2	Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie	Graz	Austria	A-8036
3	Medizinische Universität Innsbruck	Innsbruck	Austria	6020
4	Universitätsklinikum Krems	Krems an der Donau	Austria	6500
5	BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie	Linz	Austria	A-4020
6	IIIrd Medical Department, Private Medical University Hospital Salzburg	Salzburg	Austria	5020
7	Universitätsklinikum St. Pölten	St. Pölten	Austria	3100
8	Salzkammergut-Klinikum Vöcklabruck	Vöcklabruck	Austria	4840
9	Klinikum Wels-Grieskirchen GmbH	Wels	Austria	4600
10	Medizinische Universität Wien	Wien	Austria	1090
11	St. Vinzenz Krankenhaus Betriebs GmbH	Zams	Austria	6511