Studying clinical data can help to detect trends and potentially causes of cancer. It supports generating hypotheses about potential interventions that could reduce cancer incidences or morbidity. Furthermore it can help to identify and develop improved treatments. In addition, meaningful translational research requires biospecimens annotated with relevant clinical data.
Indivumed has established a unique oncology infrastructure which brings together oncology surgeons, surgical nurses, oncology practitioners, pathologists, molecular biologists, biochemists, biostatisticians and laboratory technicians. This infrastructure bridges between medical and scientific institutions and takes advantage of the specific expertise present in different environments such as surgery rooms, pathology labs and molecular and biochemical labs.
For more than 12 years Indivumed has utilized this unique oncology infrastructure to routinely collect comprehensive sets of human biospecimens from patients suffering from a variety of cancer types. This includes all relevant sample data as well as the corresponding clinical data and follow-up (longitudinal) data, all of which are useful when evaluating the distribution and determinants of health-related states in cancer patients.
Indivumed collects clinical data from medical records as well as extensive interviews with patients and their physicians. For each patient a comprehensive set of data is being collected comprising more than 250 data points per patient in the following categories:
|Clinical Data||Biospecimen Data||Follow-Up Data|
|Medical history of patient and family incl. current and previous diseases, symptoms, previous surgeries and cancers, neoadjuvant therapies||Tissue ischemia times (samples with identical ischemia times for comparative studies)||Post-surgical complications|
|Lifestyle/Quality of life||Documentation of accrual||Treatment after primary surgery|
|Tumor classification||Exact location of the sample’s excision||Survival|
|Standard routine lab test results, e.g. HIV/hepatitis serology||Anesthesiological and surgical procedures and timelines which might affect molecular pattern (time scheme of drugs administered, ligation of main arteries)||Outcome data (e.g. relapse)|
|Laboratory findings and pre-surgical diagnostic data||Histopathology and photo documentation of resected tissue|
|Complete documentation of sample storage|
The collection of all clinical data and biospecimens follows strict ethical guidelines. All data and biospecimens have been collected with full patient consent and are securely coded. All data are thoroughly cross-checked with respect to completeness, correctness and plausibility by Indivumed’s clincial data management department and are finally stored in Indivumed’s Oracle-based database, IndivuNET.
Up to now data and biospecimens have been collected from 20,000 cancer patients with a distribution among the various cancer entities as shown in Figure 1: