AGMT_NGS Registry

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

Synopsis

Short title: AGMT_NGS-Registry

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

Status: open

Start: March 2017

Coordinating Investigator: Univ. Prof. Dr. Richard Greil

NIS Number: na

ClinicalTrialsID: NCT03301493

Number of patients: 1000 (planned)

Sponsor: AGMT gemeinnützige GmbH

Link to online CRF

Design

This registry is designed as multicenter non-interventional (observational) cohort of oncology patients who received or plan to receive comprehensive genomic testing. 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.

The registry will be made available for all disciplines and physicians caring for cancer patients. Indications for genomic testing are exclusively driven by the medical need. Physicians are free to use any type of genomic test available at their hospital or from any company. The decision to use comprehensive genomic testing must be clearly separated from the decision to include the patient in the registry.

Objectives:

The goal of this registry is to landscape the clinical practice of molecular profiling in Austrian cancer patients with focus on identification of methods used, evaluation when the tests are performed in the course of the disease, and definition of the impact of the test result on the subsequent treatment decision.

  • Molecular profiling methods used in the Austrian registry centres
  • Cancer, for which comprehensive molecular profiling is used
  • 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)

Inclusion/Exclusion criteria

Inclusion criteria (selected):
  • This registry will include cancer patients for which broad genomic profiling is indicated, for example:
  • Cancer with high mutational load and suspicion of regular or fre-quent 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 per-formed but treatment fails
  • Cancer of unknown primary origin (CUP)
  • Planned or already carried out comprehensive genomic testing as of Jan 1, 2016
  • Signed written informed consent, age 18 years or older

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

Note: This registry will not initially register patients who are tested for only 1-3 mutations by conventional means, but in patients under-going genomic profiling the results of such comprehensive test systems based on NGS will be compared with previously existing tests for mutations in single or very few genes.

Register