An observational study in Cancer of Unknown Origin, Cancer Refractory and Cancer of Stomach, sponsored by Arbeitsgemeinschaft medikamentoese Tumortherapie. Completed at 11 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Arbeitsgemeinschaft medikamentoese Tumortherapie · Observational
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.
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.
101 studies on the registry are indexed under Neoplasms, Unknown Primary; 19 are open to participants now.
This study's enrollment of 1,500 is above the median of 125 across 25 observational studies indexed under Neoplasms, Unknown Primary.
Browse Neoplasms, Unknown Primary studies →Arbeitsgemeinschaft medikamentoese Tumortherapie is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice
Types of:molecular profiling methods
To describe types of:molecular profiling methods used in the Austrian registry centres
Time frame: 3 years
Types of cancer, for which comprehensive molecular profiling is used
To describe types of cancer, for which comprehensive molecular profiling is used
Time frame: 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)
Time frame: 3 years
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
Time frame: 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)
Time frame: 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
Time frame: 3 years
Outcome of treatment
To describe outcome of treatment in patients receiving therapy in concordance with the test result
Time frame: 3 years
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Arbeitsgemeinschaft medikamentoese Tumortherapie