Genomic Testing and Resulting Medical Decisions

NCT ID: NCT03301493

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-30

Study Completion Date

2024-11-30

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Genomic testing

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Greil, MD

Role: PRINCIPAL_INVESTIGATOR

IIIrd Medical Department, Private Medical University Hospital Salzburg

Locations

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IIIrd Medical Department, Private Medical University Hospital Salzburg

Salzburg, Salzburg, Austria

Site Status

Innere Medizin II, LKH Feldkirch

Feldkirch, , Austria

Site Status

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

Graz, , Austria

Site Status

Medizinische Universität Innsbruck

Innsbruck, , Austria

Site Status

Universitätsklinikum Krems

Krems, , Austria

Site Status

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

Linz, , Austria

Site Status

Universitätsklinikum St. Pölten

Sankt Pölten, , Austria

Site Status

Medizinische Universität Wien

Vienna, , Austria

Site Status

Salzkammergut-Klinikum Vöcklabruck

Vöcklabruck, , Austria

Site Status

Klinikum Wels-Grieskirchen GmbH

Wels, , Austria

Site Status

St. Vinzenz Krankenhaus Betriebs GmbH

Zams, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 34371380 (View on PubMed)

Other Identifiers

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AGMT_NGS-Registry

Identifier Type: -

Identifier Source: org_study_id

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