INDIVUMED‘s team of highly qualified study nurses participates directly in surgeries and performs biospecimen collection. Experienced laboratory scientists subsequently process the samples. This unique infrastructure provides the prerequisite for the Indivumed Standard of Biobanking and allows Indivumed to guarantee for:
Exact documented and very short tissue cold (post surgical) ischemia times of less than 8 minutes, on average, between resection and fixation. This parameter is well known to have a decisive influence on protein and gene expression patterns.
Exact tissue localization and standardized fixation. All tumor samples are obtained from defined tumor areas. In addition, each tissue sample is coded with its location in the primary tumor (central or peripheral part of the tumor). Defined tumor size vs. formalin volume ratio as well as time of fixation from each patient provides the basis for inter-tissue comparability.
Complete biospecimen sets are acquired by collecting tumor and matched normal tissue (both, FFPE and frozen tissue), corresponding blood preparations (serum, plasma, nuclear blood cell pellets) and urine (separated in supernatant and cell pellets).
Highest tissue quality monitored by visual inspection, H&E staining and microscopic assessment of tumor content and necrosis (whenever possible, as compared with intra-patient normal tissue controls). Tissue examination and quality control are performed by expert pathologists.
Native and rapid fluid preparations. All blood and urine samples are instantly cooled down to 4-8 °C and send by express courier to Indivumed s laboratories. No additives are used to assure native composition and, thus, can be used for all technology applications. Samples stay refrigerated and are processed and stored at – 80 °C within 4 hours after venous puncture.
Complete specimen data are available for all variables that might affect molecular data. Indivumed’s study nurses are present in the operating room for the entire surgery and – adopted for each surgical procedure - document quality relevant information such time of ligation of main arteries (intrasurgical ischemia), application and doses of drugs intrasurgically as well as time until fixation of tissue after surgical resection (cold ischemia).
Complete clinical data are also collected by Indivumed’s study nurses who obtain from each patient complete data sets according to a 20-page questionnaire ranging from childhood disease to life style information and disease-related medical history. An additional team of Indivumed nurses is responsible for obtaining on an annual basis comprehensive outcome and follow-up information. All data are stored in a special Oracle-data base, indivuNET, accessible for statistical and bioinformatic analysis.
Patients’ confidentiality is assured following international standards. This includes information of the Ethics-commission (IRB) and obtaining permission by the Authorities (Hamburgs Data Commisioner of the Office for Data protection). A double-coded system delinks biospecimen from patient’s identity but still allows via the clinical partners to track patients follow-up. A comprehensive consent covers all areas of cancer research and includes the right of commercial use by Indivumed and its partners.
