Study design, methods and analyses

This is a prospective observational study involving patients with cancers in the respiratory system, and we plan to enroll 300 patients with lung cancer and 100 with H&N cancer.

• Patients with head-and-neck cancer may be included if radiation therapy is the indicated treatment, and where it is possible to take biopsies.
• Lung cancer patients are included when operated, material is collected at surgery and later, from metastases when possible.
• Clinicians approach patients while hospitalised at Rikshospitalet HF and an informed consent is obtained. All tumours will be analysed at the Department of Pathology to ascertain correct hispopathological diagnosis, and tissue micro arrays will be made based upon the pathologists selection of representative areas.

Genomewide analyses of RNA expression and DNA will be performed on the biopsies taken, and the results will be correlated to tumour-response. Gene expression and aberrations, measured before start of treatment will be analyzed against clinical data to identify markers for prognostic use. Gene expression will also be analyzed against gene polymorphisms (SNP) to reveal possible associations between genetic variations in patient DNA and tumour gene expression. Moreover, the SNP data will be related to late side effects of radiation to the normal tissue, to investigate the mechanisms involved.
The microarray technology is a typical hypothesis-generating method. When correlated to clinical features or characteristics, differences in cancer biology or treatment response could be elucidated.
The improved survival seen in other cancer-diagnosis has been absent for our patient groups. We believe that a prerequisite for improving this, is enhanced insight about the molecular basis of the diseases, and investigations on how this can be incorporated in the clinical work.

By joining data from the molecular analyses with the characteristics of the patients clinical course, our goal is to identify markers that enable us to give a more personalized treatment based on establishment of novel predictive and prognostic factors as well as potential targets for novel treatment strategies.