The Alliance Biorepository at Ohio State receives, processes, stores and distributes paraffin blocks and slides, frozen tissue, peripheral blood, plasma, serum and urine from institutions participating in Alliance clinical trials. These biospecimens are used for correlative science research by approved Alliance research investigators or for NCI-approved secondary use of left over biospecimens collected for particular trials. Some biospecimens may also be used in some protocols to look at integral biomarkers that define if a patient can be enrolled in a trial.

Paraffin blocks are stored at room temperature and most unstained tissue slides are stored and vacuum packed at four degrees Celsius until needed. The ABOSU ensures that patient specimen blocks will be handled with the greatest care, never exhausting a block of material and returning the blocks to the originating hospital when requested.

• The Alliance Biorepository at Ohio State encompasses approximately 7,200 square feet of space that consists of an office (1,000 sq.ft.), laboratory space (5,400 sq.ft.) and a biorepository (2,100 sq.ft.)
• Specimens are currently stored in 16 refrigerators, 26 freezers and controlled room temperature laboratory space. The space is equipped with emergency generator backup power, a 24/7 monitoring system (Rees) and an emergency response team. It is locked 24/7 with key card access and an off-site emergency location for disaster planning
• All specimens are labelled with a specimen label that contains 2D barcode, utilizing Brady barcode solutions. The Rees Scientific Monitoring System provides 24/7 monitoring of the biorepository.

‘OpenSpecimen’ software
 
This software manages the biospecimens in the repository, which is integrated with ‘Biospecimen Management System. This is used by all CRAs at all collection sites. Digital imaging technology using Aperio scanners and eSlide Manager software is being utilized to scan some of the stained slides and conduct pathology review provided in the VML.

The Alliance for Clinical Trials in Oncology was formed in March 2011 by the merger of the American College of Surgeons Oncology Group (ACOSOG), the Cancer, Leukemia Group B (CALGB) and the North Central Cancer Treatment Group (NCCTG). The merger of these cooperative groups reflects the call in April 2010 from the Institute of Medicine to strengthen and streamline operations among NCI clinical trials cooperative group programs. In June 2010, ACOSOG, CALGB and NCCTG integrated their statistical, data management and information technology functions. In November 2010, NCI announced plans to transform the clinical trials system by reducing the number of adult cooperative groups from nine to four. Having already merged some functions, the three groups began evaluating the possibility of full integration to further streamline operations, expand their scientific research opportunities and apply for funding as a new, larger cooperative group.

In June 2011, governing boards of ACOSOG, CALGB and NCCTG endorsed a proposed Alliance constitution, bylaws and transition plan. The Transition Alliance Board of Directors then ratified the constitution and elected a new group chair, Monica M. Bertagnolli, MD, along with board members to serve on the executive committee. The first Alliance group meeting was held in November 2011 in Chicago.

The Alliance for Clinical Trials in Oncology is governed by a board of directors and executive committee, and led by a group chair and principal investigator. It is organized into five programs, each led by a co-principal investigator. These programs include the Statistics and Data Management Program, Central Protocol Operations Program, Translational Research Program, Cancer Control Program and the American College of Surgeons Clinical Research Program.

Specimen bank requests

All requests for biospecimens are reviewed through the Alliance for Clinical Trials in Oncology Translational Research Program (TRP). The Alliance welcomes concept submissions requesting utilization of existing Alliance biospecimen resources.

The correlative science concept submission process involves five steps:

1. Submission of the TRP Triage Review Form and review by the TRP Executive Committee 
2. An invitation to develop and submit a TRP Full Correlative Science Protocol
3. Full review of the developed protocol by the TRP Executive Committee
4. Submission of the TRP Executive Committee-approved protocol to the National Cancer Institute (NCI) for final review and approval
5. Completion of protocol activation requirements before the study can open

How to submit a correlative science concept

Review the following documents to ensure proper adherence to the Alliance TRP concept submission review process.

Biospecimen Concept Submission Process

Alliance Translational Research (TRP) Triage Review Form

For more information, contact Yujia Wen, MD, PhD, Director, Translational Research at 773-834-7973 or ywen@medicine.bsd.uchicago.edu.