NIAID Clinical Trials in Organ Transplantation (CTOT) (U01)

Office of Grant Writing & Publications 202 Jesse Hall University of Missouri Columbia, MO 65211 573 882-9500 phone 573 884-8371 fax

Limited Submission Announcement

The National Institute of Allergy and Infectious Diseases (NIAID) invites new or renewal applications from groups of two or more institutions to participate in a clinical studies program to improve the long-term outcome of recipients of thoracic and abdominal organ transplants. The Clinical Trials in Organ Transplantation (CTOT) program will support a cooperative, multi-institutional consortium for the conduct of interventional trials (Phase 1, 2, or 3) or observational clinical studies in organ transplantation. Each clinical study must include associated mechanistic studies that focus on immune-mediated pathologic processes in organ transplantation. The goals of this research will be to further the understanding of and ultimately reduce immune-mediated morbidity and mortality in thoracic and abdominal organ transplant receipts.

The objective of this FOA is to support multi-center interventional clinical trials and/or observational studies in pediatric and adult candidates for and recipients of organ transplantation. Studies involving children will be carried out in collaboration with the NIAID-funded Clinical Trials in Organ Transplantation in Children (CTOT-C) consortium. All clinical trials and studies must include associated studies of immunologic mechanisms performed on samples from study subjects and, if appropriate, human controls. These mechanistic studies may include cellular assays (elispot, flow cytometry, etc.), antibody assays, gene expression studies, genomic studies, or any other immunologic assays that will contribute to the scientific goals of the proposed studies.

Examples of clinical trials, observational studies and associated mechanistic studies include, but are not limited to, the following:

1. Evaluation of improved, less toxic and more specific immunosuppressive agents
2. Protocols designed to minimize pharmacologic immune suppression
3. Interventions in the donor that will result in improved recipient outcomes
4. Identification and validation of biomarkers that will enable accurate non or minimally-invasive monitoring of the recipient's immunoreactive state, so that therapy can be individualized and proactive

This FOA will not support research involving

• hematopoietic stem cell transplantation (HSCT), unless HSCT is a component of a study of organ transplantation;
• pancreatic islet transplantation for treatment of type I diabetes;
• xenotransplantation; or
• investigations in animal models, unless mechanistic assays specifically linked to a clinical study require the use of animals, e.g., a mouse footpad assay.

Applications proposing such studies will be considered non-responsive and will not be reviewed.

Because MU is limited to one application for this program, letters of intent must be submitted to the Office of Research, ltdsub@missouri.edu, no later than 4:00 p.m., Friday, July 25, 2008. Letters of intent should be limited to a 3-page summary, including 1) clinical study(ies) to be conducted; 2) how this study(ies) adds to the field of transplantation (innovation); and 3) members and affiliation of the research team.

URL for more information: http://grants1.nih.gov/grants/guide/rfa-files/RFA-AI-08-015.html

This notice is being sent to deans, directors, and chairs in health sciences. Please forward it to faculty members who may be interested.

All limited submission announcements can be tracked by deadline via the Calendar at research.missouri.edu or by announcement date via the Limited Submissions listing at http://research.missouri.edu/ogwp/lsa.htm.