Background: Different approaches for an effective quality management are funded by the Ministry of Health to verify, to assess and, if necessary to optimize the quality of health care using the tracer diagnoses of breast, rectal, and lung cancer in eight regions in Germany. The conception of these observational studies and initial findings are shown here, using breast cancer in the region of Munich (population 2.4 million) as an example. Patients and Methods: The study started on April 1, 1996. The recruitment phase for all primary boast cancer patients in this region is planned for 2 years with a 3-5-year follow-up. Established documentation sheets are used to document basic medical information of each patient, along with the original reports (pathology: radiotherapy, doctors' reports, etc.), follow-up reports and quality of life questionnaires (QLQ, including the EORTC QLQ C30). Results: In 1996, the Munich region has a crude incidence of 125/100,000 women (world standard 71.5). After almost complete documentation the incidence is 10-15% higher. In the period from April 1 1996 to June 30, 1997 1,360 patients have been recruited into the study. 79% of the patients were 50 years of age or older. pT stages are distributed as follows: pTIS 5%, pT1 54%, pT2 32%, pT3 4%, pT4 6%. 4.5% had primary metastases. Breast-conserving therapy (BCT) was performed in 57% of patients. Five of the 46 departments involved recruited more than 50 patients each within these 14 months. These larger departments treat 59% of all patients. The proportion of older patients and pT4 stages is significantly higher in the smaller departments. BCT is performed significantly more often in the larger departments. First results of quality of life show dependencies on age, but no differences between mastectomy and BCT 3 months after operation. Not only the addressed patients (response rate to QLQ over 80%) but also almost all hospitals and many physicians are milling to support and to partake in quality assurance. 35 hospitals, 46 surgical departments. 80 heads of department and surgically: active general practioners, 330 general practioners. 7 radiotherapy departments, and 13 pathology departments have so far documented for this study. Conclusions: An effective quality management in oncology needs a modern cancer registry which uses documentation sheets as well as original reports and organizes the complicated infrastructure for an interdisciplinary cooperation. To be able to evaluate the health care reality it is necessary to carry out a data analysis and assess each individual case. A feedback of the results have to be available for each physician and each department. The cost of this information management is approximately 0.3% of the health care cost for this group of patients.