Susan G. Komen for the Cure® Tissue Bank at the IU Simon Cancer Center (KTB) Defying Expectations
By banking specimens of healthy breast tissue from women of all ages and making them available to cancer researchers, a team of physicians and patient advocates in Indiana hopes to shorten the timeline to a cure and uncover new strategies for prevention of breast cancer.
KTB Donation tent at 2008 Indianapolis Race for the Cure
An estimated 182,460 new cases of breast cancer will be diagnosed in the United States this year. Though we have seen remarkable progress in the screening, diagnosis, and treatment of breast cancer, much more remains unknown, partly because our knowledge of normal breast tissue is limited by the lack of normal tissue samples available and accessible to researchers.
- Kelley H., KTB donor
Paving the Way
At a 2003 meeting of Indiana breast cancer clinicians, researchers and consumer representatives, a researcher proposed a promising study that would require samples of healthy breast tissue. Meeting participants weighed in that normal tissue would be next-to-impossible to acquire, noting that the National Cancer Institute had already identified a shortage of
normal tissue as an impediment to research. Patient advocate Connie Rufenbarger was part of that meeting and took this consensus statement as a challenge to be overcome.
Connie is a two-time cancer survivor and is described by colleagues as “the kind of person who, if you tell her something can’t be done she’ll just work even harder at it.” Shortly after the meeting, she worked with Anna Maria Storniolo, MD, a medical oncologist at the IU Simon Cancer Center, to organize ‘Friends for Life’, an effort to collect samples from volunteers at the 2005 Indianapolis Race for the Cure to supply a genetic study of normal vs. diseased breast tissue. More than 800 women donated blood samples on the first day—exceeding the study’s requirements.
Gathering Steam
Encouraged by the huge response, the team decided to repeat the event at the 2006 Race for the Cure. Ms. Rufenbarger and Dr. Storniolo were joined by Susan Clare, MD, Ph.D., a breast cancer surgeon and research chemist, and now a KTB Co-Principal Investigator who had designed a database that could house information about the donated samples. The expanded team allowed the bank to collect breast tissue cores at area hospitals and clinics to complement the blood sample collections at Race for the Cure events.
Blood samples are collected by volunteer phlebotomists
As the project gained momentum, start-up funding was provided by the Catherine Peachey Fund and the collection was renamed Mary Ellen’s Tissue Bank, in honor of one of Dr. Storniolo’s patients. In 2007, Susan G. Komen for the Cure recognized the bank’s unique mission and awarded Mary Ellen’s Tissue Bank a $1M research grant to expand its work. The bank was renamed The Susan G. Komen for the Cure® Tissue Bank at the IU Simon Cancer Center (KTB) and has been working to inform the research community about the availability of its resources.
Addressing Challenges
Establishing the bank—the first of its kind—was not without its challenges. The team felt it was critical to use the NCI’s Office of Biorepositories and Biospecimen Research Best Practices (then in draft form) as a model for their operations, a process that was costly and time-consuming but necessary to ensure the bank’s success. The database designed by Dr. Clare was modified to house information on each sample, including detailed health and medical history information from the seven-page donor questionnaire. One of the KTB’s largest hurdles was a regulatory environment that was unclear about the prospective collection of healthy tissue for research.
- Dr. Susan E. Clare, MD, PhD, Co-Principal Investigator, KTB
At the time of the bank’s inception, institutional review boards were still unsure about how to manage banking of diseased tissue for future use; collection of tissue from healthy donors was far outside the norm. Because of the unusual challenges of collecting tissue from healthy participants, the KTB team spent a significant amount of time garnering support from affiliated organizations.
Engaging and Empowering Patients and Their Loved Ones
Patients and donors needed little convincing. They quickly filled the bank with blood and tissue samples. KTB still sees a remarkable response at its donation events from breast cancer survivors and their friends and family who, despite skepticism by some doctors and researchers, just seem to ‘get it.’
“They come with the understanding that the key to cancer is to find out what makes it happen at a molecular level,” says Dr. Storniolo. “Donors understand that you can’t define ‘abnormal’ until you know what normal really is…And, until now, the only way that people have been able to participate in cancer research is unfortunately to have the cancer.” The ability to donate normal tissue engages a broader group to become a part of the solution, and their enthusiasm shows. “We have ladies that walk out and say, ‘When will you be doing this again? Can I come back?,” added Dr. Storniolo.
Women from Evansville, IN organized a bus trip to donate breast tissue to the KTB
Connie agrees. “These women have walked, they’ve written checks, they’ve lit candles—they’ve done everything they can to demonstrate they want to help. This really speaks to the fact that there isn’t a whole lot you could ask that women wouldn’t give you to cure breast cancer.”
The positive response spreads far beyond women in Indiana; the KTB has fielded requests from all over the world to hold collection drives or share their experience with others hoping to start a similar bank. After a presentation Dr. Clare gave at the 2007 Komen Annual Mission international conference, audience members lined up to speak with her. “They were asking me, can you come to my town and do this? Can you come to Dubai? Can you come to Rome?”
Taking the Model on the Road
The KTB hopes to build on this enthusiasm and set the bar even higher. In the coming year, the team plans on holding large blood donation events at the Dallas and Evansville Races for the Cure and quarterly breast tissue collection events in Indiana clinics and hospitals. The Bank will start attending Race for the Cure events around the country in an attempt to diversify its donor pool.
This will require extensive volunteer recruitment, since all events are staffed by volunteer medical professionals, and medical licensure restrictions prevent the Indiana team from collecting samples themselves at out-of-state events.
KTB will also be collecting new tissue types. The bank recently received a grant to collect fat cores so that donors’ environmental exposures can be assessed. The Principal Investigators have also begun working in conjunction with the Indiana Organ Procurement Organization to collect breast tissue samples posthumously from organ donors under the age of 18, so that development of breast tissue during childhood and puberty can be better understood.
- Betty D., KTB donor
The KTB requires researchers to return any data generated from samples back to the bank, and the team is exploring ways to make this data available for the public while ensuring donors’ privacy remain protected. The KTB will continue to document its approach and experiences so similar efforts can glean from the lessons they’ve learned and expand normal tissue banking into other cancers and other disease types.
Unwavering Commitment to Finding a Cure
A passion to find a cure for breast cancer drives the exceptional team at the KTB to take on new challenges and break new ground in biobanking and cancer research. The KTB team wants to see their samples used to drive the state of cancer research forward and shorten the timeline to a cure. While it is apparent that the founders, investigators, and patient advocates working with the KTB love what they do, it is even clearer that each one is looking forward to the day when their services are no longer needed.
