Clinical trial NCT03301493: Genomic Testing and Resulting Medical Decisions
Official title: The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: AstraZeneca
First posted: 2017-10-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Types of:molecular profiling methods
timeFrame: 3 years
measure: Types of cancer, for which comprehensive molecular profiling is used
timeFrame: 3 years
measure: Timing of molecular profiling
timeFrame: 3 years
Secondary outcomes:
measure: Number of patients with mutations identified
timeFrame: 3 years
measure: Quality standards
timeFrame: 3 years
measure: Treatment decisions
timeFrame: 3 years
measure: Outcome of treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Innere Medizin II, LKH Feldkirch
city: Graz
country: Austria
facility: Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Krems an der Donau
country: Austria
facility: Universitätsklinikum Krems
city: Linz
country: Austria
facility: BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie
city: Salzburg
country: Austria
facility: IIIrd Medical Department, Private Medical University Hospital Salzburg
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Vöcklabruck
country: Austria
facility: Salzkammergut-Klinikum Vöcklabruck
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Zams
country: Austria
facility: St. Vinzenz Krankenhaus Betriebs GmbH
Study officials:
affiliation: IIIrd Medical Department, Private Medical University Hospital Salzburg
name: Richard Greil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.