Abstract P4-13-01: Follow-Up in Biobanking — Strategy and Outcomes of Patients’ Tumor Bank of Hope (PATH)

Abstract

Abstract Purpose: Breast Cancer Patients established PATH in 2002 to collect tumor sam-ples, blood samples and data at high ethical standards and under uniform SOPs. Since 2004 more then 4500 women and men in Germany gave their informed consent for the collection. In addition, PATH has successfully started to collect follow-up data from all patients, covering both disease and therapy process. Design: Specimen (tumor, normal tissue, blood serum) are stored in liquid nitrogen tanks (fresh frozen quality) operated by pathologists at seven certified breast cancer centers in Germany. To provide a benefit for the donors, the first aliquot is stored exclusively for the patient. The rest of the material is donated to research purposes. Processing, handling and labelling of the samples is defined in rigid SOPs, accompanied by monitoring. Data regarding clinical findings, tumor-biology and sample processing are collected and centrally managed. In order to annotate the samples follow up started in early 2009. As a patient driven, non-profit organization PATH has a special reliability. Thus, the Foundation is given the right to establish direct contact with any patient that has given informed con-sent. This approach was confirmed by ethics committee, the Bavarian Commission of Data Protection and a university professor of medical law. In order to get the follow-up data, PATH contacts the patient by letter. A structured phone call follows, carried out by female medical students, who are specially trained. The patient is asked to provide details on their individual course of disease. Additionally they are asked about their compliance with therapy. Procedure, data volume and data quality are specified and standardized. If patients could not be reached by call they are asked to complete an additionally mailed questionnaire. As the last source for data PATH will try to get data from tumor registers. In case of re-currence the data obtained from the patients is validated by check-ups with medical reports from the practitioners. Results: By May 2010 more than 4500 patients gave informed consent. 4042 cases have been documented in their entirety in the data base. 75% have stored a patient's tumor specimen and 61% a research tumor sample in the bio bank. As many patients have multiple samples there is a total of 4080 tumor specimen, 9029 blood serum and 4075 normal tissue aliquots for research purposes. 2253 cases were contacted for follow up, 1491 (66,2%) patients were interviewed by phone and 142 (6,3%) women returned the questionnaire. In 72,5% of the con-tacted cases follow-up data is available. The mean age of all patients who do-nated their tumor specimen is 60,3 years. 78,9% of the tumors are ER-positive, 11,4% triple negative. The data includes 20 cases of recurrence and 61 cases of metastases. Conclusion: Within 16 months PATH contacted 40% of all patients included in the bio bank and gained follow up data. Thus PATH will provide a great variety and quantity of fresh frozen tissue and blood samples with excellent quality and a mean follow up of 5 years in less than 12 months. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P4-13-01.