Genomic Testing and Resulting Medical Decisions

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status: Completed

Conditions: Cancer, Kidney; Cancer, Breast; Cancer, Uterus; Cancer Liver; Cancer of Esophagus; Cancer Refractory; Cancer, Lung; Cancer Head Neck; Hematologic Neoplasms; Cancer of Unknown Origin; Cancer of Stomach; Cancer, Bladder; Cancer Cervix; Cancer of Skin; Cancer Colorectal

Treatments: Other: Genomic testing

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03301493

AGMT_NGS-Registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.