44P - The PATH biobank: Re-consenting patients regarding genomic research

Date 08 May 2014
Event IMPAKT 2014
Session Welcome reception and Poster Walk
Topics Bioethics, Legal, and Economic Issues
Breast Cancer
Translational Research
Presenter Cathrin Mayer
Citation Annals of Oncology (2014) 25 (suppl_1): i8-i16. 10.1093/annonc/mdu066
Authors C. Mayer1, U. Ohlms2, D. Schmitt2, C. Waldner2, H. Bodenmueller2, T. Anzeneder2
  • 1Project Management, Stiftung PATH - Patients' Tumor Bank of Hope, 81371 - Munich/DE
  • 2Project Management, Stiftung PATH - Patients' Tumor Bank of Hope, 81337 - Munich/DE

Abstract

Introduction:

PATH is a biobank providing high-quality fresh-frozen breast cancer specimen to research groups. Being a patient-driven foundation, PATH operates according to high ethical standards. The need for a re-consent for genomic wide association studies (GWAS) on biobank material is a subject of controversial discussion. Here, we present an overview about our biobank and our approach for obtaining consent to GWAS.

Procedures:

The PATH biobank consists of a centralized database and a decentralized biorepository. The samples are collected and stored in seven institutes for pathology at certified German breast cancer centers. Tumor tissue, along with normal adjacent tissue and blood serum aliquots are processed, labeled and stored according to unique SOPs. Informed consent for the storage of their specimen and its use for research is obtained from patients before storage in the biobank. However, GWAS have not been explicitly mentioned in these consent forms. A letter explaining risks and benefits associated with GWAS and a re-consent form for GWAS were sent to 31 patients in a pilot trial.

Results:

Since 2004, more than 7,200 breast cancer patients have given their informed consent to the storage and analysis of their tissue and blood serum for research purposes. Tumor stages T1 or T2 were present in 93% of donors. Overall, 81% were ER +, 71% PR+ and 13% HER2-neu+. A subgroup of 11% were triple negative. PATH material was successfully used for a number of publications from different research groups. In a pilot trial, 11/31 patients agreed to the use of their tissue for GWAS after receiving one letter, 6/31 had deceased and 3/31 were untraceable.

Conclusion:

The PATH biobank, along with its detailed clinical and follow up information, is a valuable resource for breast cancer research. PATH will set out to ask all specimen donors for their consent to GWAS. Patients not responding to the first letter will receive at least one more letter. We will also try to increase the response rate by enclosing a newsletter along with the consent request. A subset of PATH material will be available for GWAS after re-consent of the respective donors.

Disclosure:

All authors have declared no conflicts of interest.