AzTrials
AzTrials

Cancer of Unknown OriginNCT03301493

Genomic Testing and Resulting Medical Decisions

An observational study of Cancer of Unknown Origin and Cancer Refractory, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 11 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Genomic testing
How many people
1,500 participants
Where
11 sitesAustria
Study dates
30 Mar 2017to 30 Nov 2024
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • Due to the non-interventional design of the registry there are no specific exclusion criteria.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Austria11 sites

  • Innere Medizin II, LKH Feldkirch

    Feldkirch, 6807

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

    Graz, A-8036

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Universitätsklinikum Krems

    Krems, 6500

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

    Linz, A-4020

  • IIIrd Medical Department, Private Medical University Hospital Salzburg

    Salzburg, State of Salzburg, 5020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

  • Medizinische Universität Wien

    Vienna, 1090

  • Salzkammergut-Klinikum Vöcklabruck

    Vöcklabruck, 4840

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

  • St. Vinzenz Krankenhaus Betriebs GmbH

    Zams, 6511

Other trials in Austria

About this study

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

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.

Read the 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.

Being tested
Genomic testing
Medical subject headings
Neoplasms, Unknown Primary, Stomach Neoplasms, Head and Neck Neoplasms, Skin Neoplasms, Lung Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genomic testingOther

    Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Types of:molecular profiling methods

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

    Measured: 3 years

  2. Types of cancer, for which comprehensive molecular profiling is used

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

    Measured: 3 years

  3. 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)

    Measured: 3 years

Secondary outcomes (4)

  1. 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

    Measured: 3 years

  2. 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)

    Measured: 3 years

  3. 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

    Measured: 3 years

  4. Outcome of treatment

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2017
  2. Study start30 Mar 2017
  3. Primary completion31 Dec 2023
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
1,500 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03301493
Sponsor's protocol ID
AGMT_NGS-Registry
Status last verified
Apr 2025
First submitted
22 Sep 2017
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34371380

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer of Unknown Origin and Cancer Refractory, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 11 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Types of:molecular profiling methods (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03301493, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in