Use Cases

Use cases

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Support in Therapy Decision-Making upon Molecular Diagnosis

Overview

Within the MASTER program, tumor biopsies from NCT patients with rare oncological diseases or complex progressions undergo extensive molecular testing in order to determine clinically relevant patient- and/or tumor-specific mutations. Based on these molecular modifications, individual therapies or clinical trials that can positively influence the progression shall be identified.

Status Quo

DKFZ’s bioinformatics experts are currently processing the results of the molecular testing and making them available to the NCT oncologists as a spreadsheet. Usually there are several hundreds of modifications per patient that the oncologist evaluates with the help of external knowledge databases concerning their therapeutic significance and the option of recruiting the patient into a clinical trial. The therapy decision has to take into account non-genetic clinical data as well. Overall, this is a very time-consuming task.

Support from the DTH

By integrating the genetic data from bioinformatics and the clinical data from the cancer registry in the DTH, we can provide our oncologists with the comprehensive overview of a patient they require in order arrive at a therapy decision. The link to external knowledge databases providing information on clinical trials and drugs related to genetic mutations enables the oncologists to make a therapy decision considering the molecular data within a very short time.

Key Features

  • Doctors can access the records of individual patients participating in the MASTER program based on identifying data (IDAT; ideally first and last name) or Xten (available from the PSN service at the clinical trial center) and view their genetic and clinical data.
  • These data are processed and displayed in a special way for the MASTER program.
  • Possible therapies and clinical trials are pointed out. The hints to them stem from external knowledge databases.

Statistical Analyses

Overview

The DTH allows for detailed analyses of the patient flows within NCT. It offers the option of building cohorts based on clinical data and determining their size within a given time frame (e.g. per quarter).

A simple example: How many patients diagnosed with colorectal carcinoma are being treated at NCT every quarter?

Status Quo

At the moment, the goals described above are reached by various time-consuming queries to the hospital information system (HIS) and the NCT patient registry. In the HIS, these require special access rights the administrative staff does not have; therefore, the queries are placed by IT administrators. In the registry, this task is carried out by the IT department. This makes autonomous, up-to-date statistical queries impossible.

Support from the DTH

By integrating the clinical data from the HIS and the NCT registry in the DTH, and thanks to fine-grained access rights, administrative staff can place such simple statistical queries.

The greater the amount of structured data in the DTH (e.g. if more hospital systems are integrated), the more complex the queries that may be placed.

Key Features

  • Staff without IDAT access rights must be able to do statistical analyses autonomously.
  • This does not necessarily have to be possible on an up-to-date basis, but the delay of the NCT registry should be undercut considerably.

Support in the Recruitment of Patients for Clinical Trials

Overview

NCT aims at affording every oncological patient at Heidelberg University Hospital the option of participating in an innovative clinical trial. This requires intensive support in the recruitment process due to exceedingly complex inclusion and exclusion criteria.

Status Quo

There are currently different approaches to identifying potential participants in clinical trials.

  1. The attending doctors point out potential study patients and the clinical trial offices review their eligibility.
  2. Using the work lists of the oncological outpatient clinics, the clinical trial offices search Heidelberg University Hospital’s HIS for potential study patients.

Inclusion and exclusion criteria can be very complex and rich in detail. Only rarely are all of them included in clinical documentation systems, and if so, they are scattered across different documents in one system or even several systems. Accordingly, comparing all of them is a very time-consuming task.

Support from the DTH

Through the availability in the DTH of both relevant information on all oncological trials as well as clinical data on all oncological patients at NCT, the clinical trial offices are able to perform targeted searches for all potential trial participants in one system.
Even the DTH will never contain all inclusion and exclusion criteria in a structured manner – but a pre-filtering of recurring criteria shall reduce the work load for recruitment.
Collaboration features such as circulating information on patients identified in the SAP Web application Medical Research Insights (MRI) to trial doctors and assistants, commenting features, establishment of workflows etc. would be desirable.

Key Features

  1. Display of potential study patients in a bar graph and as a spreadsheet (number, IDAT)
  2. Display criteria: the relevant subset of inclusion and exclusion criteria documented in the source systems
  3. Switch from the spreadsheet view to the patient history; subsequent browsing through the patient history of all patients included in the cohort.
  4. Switch from the spreadsheet view and the patient history to the patient’s document list in the HIS
  5. Support of the HIS authorization scheme
  6. Collaborative features for staff participating in the trial

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