Genomic Testing and Resulting Medical Decisions

Completed

• Conditions: Cancer Refractory; Cancer Head Neck; Cancer, Lung; Cancer of Esophagus; Cancer Cervix; Cancer Liver; Cancer, Kidney; Hematologic Neoplasms; Cancer of Stomach; Cancer, Breast

• Registration Number: NCT03301493
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2017-03-30
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-04
• Primary Completion: 2023-12-31
• Study Completion: 2024-11-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (11)

Klinikum Wels-Grieskirchen GmbH; 🇦🇹 Wels, Austria

Medizinische Universität Wien; 🇦🇹 Wien, Austria

St. Vinzenz Krankenhaus Betriebs GmbH; 🇦🇹 Zams, 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 an der Donau, Austria

BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie; 🇦🇹 Linz, Austria

IIIrd Medical Department, Private Medical University Hospital Salzburg; 🇦🇹 Salzburg, Austria

Universitätsklinikum St. Pölten; 🇦🇹 St. Pölten, Austria

Salzkammergut-Klinikum Vöcklabruck; 🇦🇹 Vöcklabruck, Austria