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Scientific Concept of the National Cohort (status ... - Nationale Kohorte

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Retrieval <strong>of</strong> biomaterials<br />

123<br />

A.3 Study design<br />

After finishing <strong>the</strong> recruitment phase, researchers can apply for data and biomaterials <strong>of</strong><br />

<strong>the</strong> <strong>National</strong> <strong>Cohort</strong> in <strong>the</strong> context <strong>of</strong> a scientific project (see also figure 3.3). After a positive<br />

vote <strong>of</strong> <strong>the</strong> Use and Access Committee, <strong>the</strong> samples will be selected and processed<br />

as agreed. Researchers must finance <strong>the</strong> transport, <strong>the</strong> extraction <strong>of</strong> DNA and RNA, and<br />

molecular analyses <strong>of</strong> <strong>the</strong> samples from <strong>the</strong>ir own budget.<br />

Suggested site for <strong>the</strong> central biobank (HMGU, Munich)<br />

Helmholtz Center Munich (HMGU) has a long-lasting experience in biobanking. Currently,<br />

approx. 1.6 million plasma and serum aliquots from 60,000 subjects are stored, as well as<br />

15,000 DNA samples, 6,000 RNA samples, and 4,000 cell lines. During <strong>the</strong> last 3 years,<br />

about biosamples for 150 studieshave been retrieved for collaborative projects.<br />

HMGU is coordinating <strong>the</strong> “Biobank Alliance” as part <strong>of</strong> <strong>the</strong> “m4 Excellence Cluster” funded<br />

by BMBF. H.-E. Wichmann is German coordinator <strong>of</strong> <strong>the</strong> European Biobank Reseach Initiative<br />

BBMRI. In Munich <strong>the</strong> BBMRI Catalogue <strong>of</strong> 280 biobanks registered in BBMRI is<br />

hosted.<br />

In addition, HMGU has broad experience in extraction <strong>of</strong> DNA, genotyping, transcriptomics,<br />

metabolomics, and (beginning) epigenomics.<br />

A.3.5.5 development <strong>of</strong> a tumor biobank for histologic and molecular tumor<br />

subclassification<br />

<strong>Concept</strong> for tumor tissue biobank<br />

As discussed in Sect. A.2, tumors from many organ sites exhibit different molecular subtypes,<br />

and it is increasingly being recognized that subtypes <strong>of</strong> tumors develop along different<br />

pathways and show different epidemiologic risk factors. Thus, for future research on <strong>the</strong><br />

risk factors and etiology <strong>of</strong> cancer, it will be <strong>of</strong> utmost importance to have detailed knowledge<br />

about <strong>the</strong> morphologic and molecular characteristics <strong>of</strong> <strong>the</strong> tumors from all cases with<br />

<strong>the</strong> most frequent forms <strong>of</strong> incident cancer within <strong>the</strong> <strong>National</strong> <strong>Cohort</strong>. For morphologic and<br />

molecular subclassification <strong>of</strong> tumor types within <strong>the</strong> <strong>National</strong> <strong>Cohort</strong>, we propose that a<br />

quality-assured central biorepository <strong>of</strong> tumor samples be installed at <strong>the</strong> Pathology Institute<br />

<strong>of</strong> <strong>the</strong> University <strong>of</strong> Heidelberg in collaboration with <strong>the</strong> <strong>National</strong> Center for Tumor Diseases<br />

(NCT) in Heidelberg. After <strong>the</strong> paraffin-embedded tumor blocks have been collected<br />

to <strong>the</strong> central repository, relevant derivatives <strong>of</strong> <strong>the</strong>se will be prepared, such as sections and<br />

tissue microarrays for immunohistochemistry, as well as nuclear acid extracts for analyzing<br />

epigenetic markers and genetic mutation pr<strong>of</strong>iles.<br />

The collection and subsequent analyses <strong>of</strong> tumor tissues <strong>of</strong> incident cancer cases, in conjunction<br />

with <strong>the</strong> extensive risk factor information and fur<strong>the</strong>r measurements that can be<br />

made in blood and o<strong>the</strong>r biomaterials, will make it possible to perform statistical analyses<br />

addressing cancer etiology that are <strong>of</strong> unsurpassed depth. In addition, <strong>the</strong> systematic collection<br />

<strong>of</strong> tumor materials within <strong>the</strong> <strong>National</strong> <strong>Cohort</strong> will provide a systematic description<br />

<strong>of</strong> molecular tumor characteristics for an epidemiologically defined population across Germany.<br />

Requirements for tumor collection<br />

Tissue: For diagnosis (biopsy) and during surgery (resection) tumor tissues generally are<br />

obtained and sent to <strong>the</strong> respective pathological institutes, where <strong>the</strong> samples are <strong>the</strong>n<br />

A.3

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