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Clinical/Sample Data: IndivuNET Database

The core of INDIVUMED's IAP is the database indivuNET, an Oracle-based databank. Because of the comprehensiveness and accuracy of its clinical and sample data, indivuNET provides a unique tool for data mining and, thus, efficient research. Clinical data are not only transferred from the medical record but also obtained through extensive interviews of the patients and their treating physicians conducted by INDIVUMED's study nurses. Blood test results determined by different hospitals are standardized through additional measurements in one central clinical laboratory. HIV and hepatitis serology are routinely examined. Follow-up data are obtained by interviewing patients at outpatient clinics located at each of its partner hospitals and by contacting their physicians. Information on sample collection procedures, transportation and storage are documented meticulously.

Detailed information about data collection can be obtained on request. The following information is available:
·  Comprehensive data about collection, preparation, and storage of    tissue and fluid samples, including
       - Photo documentation of resected organs and tumors
       - Tissue ischemia times (samples with identical ischemia times for          comparative patient studies are available)
       - Exact location of the probe excision
·  Documentation of surgery, including
       - Surgical steps which might affect molecular pattern (e.g.,ligation          of main arteries)
       - Anesthesiological procedures (e.g., all drugs with exact time          documentation in relation to tissue accrual)
·  Comprehensive clinical data of patients
       - Complete medical record
       - Standardized routine lab test results including HIV/hepatitis          serology
       - Histopathology
       - Postsurgical complications
·  Follow-up data
       - Treatment after primary operation
       - Quality of life
       - Relapse-free survival
       - Overall cancer-related survival
·  Quality control
       - Documentation of accrual (transportation time, temperature,          etc.)
       - Continuous documentation of sample storage
       - Analysis of samples (e.g., RNA quality)

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