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U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine
Last Updated: 04/25/2012


Strategic Partnering to Evaluate Cancer Signatures


Tracy Lively, Ph.D.

The Strategic Partnering to Evaluate Cancer Signatures (SPECS) program consists of a group of grants that support multi-institutional, multidisciplinary research teams. The SPECS program leverages NCI’s investment in cancer clinical trials, cancer centers, NCI intramural programs, and the Specialized Programs of Research Excellence (SPORE) program. The projects include collaborations with biotechnology companies, community hospitals, national laboratories, and academic institutions in the United States, Canada, and Europe.

The SPECS initiative supports large collaborative research groups that are exploring how information derived from comprehensive molecular analyses can be used to impact the care of cancer patients and ultimately improve outcomes.  SPECS supports research that bridges the gap between the discovery of molecular sig­natures and their integration into clinical practice. Investigators are refining and confirming both genomic and proteomic signatures that have already been shown to address clinical needs or questions. They are defining the critical components of the signatures and developing robust assays for measuring those components in the clinical setting. They will confirm that the modified signatures provide reproduc­ible, reliable information that can poten­tially inform clinical decision making. Several of the signatures developed in SPECS will be evaluated in prospective clinical trials.

The SPECS I Network (2004-present)

The first set of SPECS projects were funded in response to a Request for Applications in 2004 (RFA CA-04-015). The SPECS I network supported six consortia to work on signatures in breast cancer, lung cancer, prostate cancer, lymphoma, leukemia, and sarcomas.

Strategic Partnering to Evaluate Cancer Signatures Projects

Childrens Hospital Los Angeles
Los Angeles, CA — Sarcoma scientificPrograms/specs/diagnostic_ prognostic_sarcoma.htm

Principal Investigator
Timothy J. Triche, M.D., Ph.D.

This project is refining and validating molecular signatures that provide a more accurate diagnosis and that more accurately predict clinical behavior of common childhood sarcomas. Plans are under discussion with the Children’s Oncology Group (COG) to incorporate a diagnostic signature for rhabdomyosarcomas into COG clinical trials.


University of California
Irvine, CA — Prostate scientificPrograms/specs/evaluations_ predictive_signatures.htm

Principal Investigator
Dan Mercola, M.D., Ph.D.

This project is refining and validating molecular signatures that predict relapse in prostate cancer patients and that distinguish indolent disease from disease that will progress. A clinical version of the assay is being evaluated in collaboration with Althea Diagnostics, a small diagnostics company.


University of Nebraska Medical Center
maha, NE — Lymphoma projectdetail.jsp?ProjectID=92117

Principal Investigator
Wing C. Chan, M.D.

This project is refining and validating diagnostic and prognostic molecular signatures for the major subclasses of non-Hodgkin lymphoma. This project is a collaboration between the University of Nebraska Medical Center, NCI investigators, investigators from the clinical cooperative groups, and investigators from five international institutions.

University of New Mexico
Albuquerque, NM — Leukemia scientificPrograms/specs/leukemia_ signatures_risk.htm

Principal Investigator
Cheryl L. Willman, M.D.

This project is refining and validating molecular signatures that improve risk classification and predic­tion of response to therapy in pediatric and adult ALL. A plan to incorporate a signature that predicts minimal residual disease in children with high-risk ALL into COG clinical trials is under discussion.


Vanderbilt-Ingram Cancer Center
Nashville, TN — Lung Cancer scientificPrograms/specs/molecular_ signatures_lung_cancer.htm

Principal Investigator
David P. Carbone, M.D., Ph.D.

This project is refining and validating molecular signatures in lung cancer, including serum proteomic signatures that differentiate patients with can­cer from those without disease, signatures that predict risk of recurrence following surgery, and signatures that predict response to EGFR-targeted therapies. A clinical trial evaluating the signature that predicts response to anti-EGFR therapies is underway in collaboration with Genentech.


Washington University
St. Louis, MO — Breast Cancer scientificPrograms/specs/biological_ breast_cancer_classification.htm

Principal Investigator
Matthew J. Ellis, M.D., Ph.D.

This project is refining and validating a molecular signature, PAM50, that identifies four “intrinsic” subtypes of breast tumors using quan­titative polymerase chain reaction to measure gene expression in formalin-fixed, paraffin-embedded tissues. This signatures will add useful information to the established diagnostic categories of breast cancer and help avoid either under- or over-treatment.

The investment in the SPECS I projects is being leveraged in the Therapeutically Applicable Research to Generate Effective Treatments (TARGET) developed in collaboration with CTEP and the NCI Office of Cancer Genomics (http://target/ Gene expression data on over 200 high-risk pediatric acute lymphoblastic leukemia (ALL) patients generated in the leukemia SPECS project are being combined with data on genomic alterations being developed on the same patients by investigators at St. Jude Children’s Research Hospital. The combined data are being used to identify genes altered in ALL that are candidates for sequencing. Approximately 200 genes are being sequenced to identify mutations that may be potential targets for drug development. A second TARGET project has been initiated to take advantage of the gene expression data being developed on the SPECS pediatric sarcoma project.

Funds from the American Recovery and Reinvestment Act (ARRA) of 2009 accelerated several of the SPECS I projects. Antibodies to components of the proteomic signatures identified in the lung cancer SPECS project are being produced with ARRA support to the NCI Clinical Proteomics Center at Vanderbilt University. An ARRA supplement to the lymphoma SPECS project will support the translation of gene expression signatures developed using frozen tumor tissue into assays that can be performed on samples of formalin-fixed, paraffin-embedded tissue. This will accelerate the application of the new assay in routine clinical practice. And ARRA support will be used to test the breast cancer gene expression signature developed at Washington University on specimens collected from several large phase 3 clinical trials, in order to support an application for regulatory clearance of this assay by the FDA. Funding from ARRA has also permitted expansion of the TARGET program, so that its current portfolio of childhood cancers includes high-risk acute lymphoblastic leukemia, acute myelogenous leukemia, osteosarcoma, neuroblastoma, and Wilms tumor.