Genomic Testing and Resulting Medical Decisions
The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification
1 other identifier
observational
1,500
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2017
CompletedFirst Submitted
Initial submission to the registry
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
October 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedApril 10, 2025
April 1, 2025
6.8 years
September 22, 2017
April 9, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Number of patients with mutations identified
3 years
Quality standards
3 years
Treatment decisions
3 years
Outcome of treatment
3 years
Interventions
Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice
Eligibility Criteria
A cohort of oncology patients who received or plan to receive comprehensive genomic testing anytime on or after January 1, 2016. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arbeitsgemeinschaft medikamentoese Tumortherapielead
- Roche Pharma AGcollaborator
- AstraZenecacollaborator
Study Sites (11)
IIIrd Medical Department, Private Medical University Hospital Salzburg
Salzburg, Salzburg, 5020, Austria
Innere Medizin II, LKH Feldkirch
Feldkirch, 6807, Austria
Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie
Graz, A-8036, Austria
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Universitätsklinikum Krems
Krems, 6500, Austria
BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie
Linz, A-4020, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, 3100, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Salzkammergut-Klinikum Vöcklabruck
Vöcklabruck, 4840, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
St. Vinzenz Krankenhaus Betriebs GmbH
Zams, 6511, Austria
Related Publications (1)
Heregger R, Huemer F, Hutarew G, Hecht S, Cheveresan L, Kotzot D, Schamschula E, Rinnerthaler G, Melchardt T, Weiss L, Greil R. Sustained response to brigatinib in a patient with refractory metastatic pheochromocytoma harboring R1192P anaplastic lymphoma kinase mutation: a case report from the Austrian Group Medical Tumor Therapy next-generation sequencing registry and discussion of the literature. ESMO Open. 2021 Aug;6(4):100233. doi: 10.1016/j.esmoop.2021.100233. Epub 2021 Aug 7.
PMID: 34371380DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Greil, MD
IIIrd Medical Department, Private Medical University Hospital Salzburg
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2017
First Posted
October 4, 2017
Study Start
March 30, 2017
Primary Completion
December 31, 2023
Study Completion
November 30, 2024
Last Updated
April 10, 2025
Record last verified: 2025-04