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Clinical Studies

Breast Cancer Biomarkers

Investigators at the Canary Center at Stanford are collaborating with researchers and clinicians at the Stanford Cancer Institute on a project to identify gene expression and protein changes in patient specimens as breast cancer develops, and to determine whether those changes correlate with specific imaging findings.

The team is establishing a Stanford University tissue bank of matched tumor and normal breast biopsy samples, mammography, ultrasound, magnetic resonance imaging studies, and blood samples.

The team will integrate the data and identify correlations between plasma protein and tumor gene expression profiles, pathology, and radiographic imaging studies. The dataset will represent the most comprehensive analysis of its kind to date. Potential biomarkers that signal the development of the tumor would form the basis for early detection blood tests to complement imaging.

Additional work aims to identify biomarkers that distinguish women with cancer from those with benign conditions (such as a cyst). These biomarkers would potentially reduce the number of unnecessary invasive follow-up tests and enhance the interpretation of mammographic images for early detection of breast cancer.

Breast Cancer Imaging

New imaging approaches may provide a more sensitive and more accurate approach for the detection of breast cancers. We are testing several imaging alternatives, including a new PET imaging agent, enhanced ultrasound using targeted microbubbles, and photoacoustic imaging, for their ability to identify breast cancer early and to better distinguish cancer and benign conditions.

Prostate Active Surveillance Study (PASS)

The Canary Prostate Active Surveillance Study (PASS) was launched in 2008 in response to the growing evidence of overtreatment of prostate cancer and a need for tools to tell the difference between aggressive and indolent prostate cancer.

Active surveillance is an accepted standard of care option to manage low-risk prostate cancers. Active surveillance involves careful monitoring by serial prostate biopsy, clinical exam and prostate specific antigen (PSA) tests. If the low-risk cancers show signs of more aggressive behavior during the monitoring, then they can be treated at that time. This spares many men the potential side effects and cost of immediate treatment.

PASS is a multi-center study enrolling men with early-stage prostate cancer who elect to manage their cancer by being actively monitored (with PSA measurements, clinical exams, and repeat biopsies), donating specimens as they are being followed for five years. Intervention such as radiation treatment or surgery is offered if evidence of a more aggressive or growing tumor develops. After five years have passed or after treatment has been received, long-term outcome data continue to be collected.

PASS has enrolled more than 1,100 men, each of whom is being followed for five years. The trial has collected more than 200,000 specimens. Adherence to protocols, clinical information databases, and specimen collections are managed and maintained centrally. Procedures and legal agreements are in place to share data and specimens; PASS distributes specimens from its central facility for use in approved studies. To apply to conduct studies using PASS biological specimens, submit the PASS Project application.

Additional Information

To find out more about PASS, please visit

To find out more about prostate cancer, please visit National Cancer Institute or contact the National Cancer Institute’s Cancer Information Service at 1-800-4-Cancer (1-800-422-6237) or TTY: 1-800-332-8615. In Canada, call the Canadian Cancer Society’s Cancer Information Service at 1-888-939-3333

Study Sites and Contacts
Beth Israel Deaconess Medical Center/Harvard Medical School
Andrew Wagner, MD

Eastern Virginia Medical School
Leigh Ann Brand, CCRP

Stanford University
Michelle Ferrari, RN

University of British Columbia
Jonathan Ma
604-875-4111 Ext. 66557

University of California, San Francisco
Samuel Chadwick
Imelda Tenggara-Hunter

University of Michigan PASS
Rabia Siddiqu

University of Texas Health Science Center, San Antonio
Heather Mullis
210- 567-1172

University of Washington
Chenee Holcomb

Veterans Affairs Puget Sound Health Care System
Branda Levchak

The Canary Tissue Microarray (TMA) Resource

The Canary Foundation Retrospective Prostate Tissue Microarray Resource is a multicenter, retrospective prostate cancer tissue microarray cohort designed to validate biomarkers of prostate cancer recurrence after surgery.

The resource will confirm the predictive power of previously discovered tissue biomarkers of aggressive cancer. The TMA’s represent over 1,000 patients selected using a rigorous statistical design from six participating institutions in the United States and Canada, capturing the heterogeneity of screening and clinical practices in the contemporary North American population. Standardized clinical data are collected in a centralized database.

Canary’s Studies in Imaging for Prostate Cancer

New imaging approaches may provide a more sensitive and more accurate approach for the detection of prostate cancers. We are testing two new techniques, enhanced ultrasound using targeted microbubbles and photoacoustic imaging, for their utility in prostate cancer screening.

Bringing Biomarkers into the Clinic

Part of the Canary strategy is to develop industry partnerships to validate biomarker panels for the prediction of prostate cancer aggressiveness and bring the biomarkers into clinical use in the near term.

This will give patients and physicians better decision-making tools, which should reduce overtreatment and identify men who may benefit from early treatment. The Canary team is collaborating with several companies that are developing biomarkers, including Genomic Health Inc., OPKO Diagnostics, and Hologic. These biomarkers are tested in tissue, blood, and urine, respectively.

Novel Markers Trial (NMT) for Ovarian Cancer Screening

The Novel Markers Trial (NMT) was launched in 2009 by the Pacific Ovarian Cancer Research Consortium (POCRC), a collaborative team of scientists led by Canary team member Dr. Nicole Urban who was awarded a five-year SPORE grant by the National Cancer Institute.

Previous clinical trials of ovarian cancer screening programs mostly involved a single biomarker (CA-125) as a blood test. The NMT incorporates a second blood-based biomarker (HE4) into the screening protocols for clinical decision-making. Furthermore, the trial uses a new computational algorithm to determine whether the biomarker signals the presence of cancer. The study is determining the predictive value for malignant ovarian cancer of a screening program that includes the two blood biomarkers, the new algorithm to decipher a cancer signature from blood biomarkers, and ultrasound as an imaging modality.

The five-year study has enrolled its goal of 1,200 women, divided into three risk groups depending on the mutation status of certain cancer risk genes, family history of ovarian cancer, and other factors that may influence a woman’s risk of ovarian cancer. The study has determined that HE4 is useful as a confirmatory screen when rising CA-125 is used alone as a primary screen. The screening protocol was found to be feasible and acceptable to women and physicians and did not result in excessive imaging, surgical consults or surgeries. Thousands of well-characterized samples, including blood and tissue specimens, are now stored in a central repository for use in future studies. The NMT is under consideration to be made available nationally through an NCI-funded cancer research cooperative group.

For more detailed information about this screening trial, please visit the POCRC website.

Imaging for Ovarian Cancer

There is a need for new imaging technologies that not only reliably visualize ovarian cancer with enhanced sensitivity and specificity but also differentiate between benign and malignant disease.

The ovarian cancer team will test a new technique, photoacoustic imaging, for its ability to meet these needs in ovarian cancer screening. Another molecular imaging modality that holds promise for imaging ovarian cancer is enhanced ultrasound using targeted microbubble technology. Recent FDA approval for using targeted microbubbles in humans has opened the door to advance this study.

Risk Assessment, Prevention and Surveillance in Ovarian Cancer

The Ovarian Cancer team has designed the Risk Assessment, Prevention and Surveillance (RAPS) study to build upon developments in the field in the last decade regarding the role of the fallopian tube in the progress of lethal ovarian cancer.

Fallopian tube removal can potentially prevent up to 50 percent of the incidence of ovarian cancer. Although controversial, both the Society of Gynecological Oncologists of Canada and scientific advisors of the Helene Harris Memorial Trust in the United Kingdom have advised that complete removal of the fallopian tube should be considered for all women undergoing hysterectomy. Fallopian tube removal is being promoted to clinicians in some areas of North America, but women are largely unaware of this emerging option for ovarian cancer prevention.

Collaborative 5-Year Study to Combine Imaging and Biomarkers for Lung Cancer

Partner stakeholders and collaborating institutions, including Canary Foundation and MD Anderson Cancer Center in Houston, Texas, are launching a clinical trial in which blood biomarker data will be incorporated into the CT screening process for lung cancer. The trial will enroll at least 10,000 individuals to be followed for three to five years at a minimum of 10 participating sites in the U.S.

At each visit, participants receive a CT scan, a questionnaire that includes detailed smoking history, and a blood draw. All participating sites will incorporate the same sets of Standard Operating Procedures for protocol design, specimen collection, processing, storage, and shipping.

Biomarkers will be tested for their ability to detect lung cancer and to discriminate cancer versus benign conditions in suspicious CT findings. Biomarkers will also be tested for their ability to predict a risk profile for lung cancer. Top biomarkers include those discovered and validated through the Canary Lung Team’s previous research on blood and tissues from lung cancers that developed in individuals who never smoked. The team is also evaluating all biomarkers that show promise from studies worldwide so that the most promising biomarkers can qualify for validation using samples from this prospective screening trial.

Where Canary Science is Happening