ALCMI is already helping to revolutionize the current standard of care for lung cancer patients through our inaugural collaborative research project - Collaborative Advanced Stage Tissue Lung Cancer Network - termed CASTLE. This clinical trial was launched in November 2010 and is collecting tumor tissues, blood and clinical data from advanced stage lung cancer patients. ALCMI offers this one-of-a-kind research resource for investigators around the globe.
The CASTLE Network study is open in the United States and will be opening in Europe in 2012.
At therapeutic decision points, highly annotated, prospective tumor and blood samples are collected
• Enrolled subjects are followed throughout their lifetime or for as long as they decide to participate in the study
• A Biorepository of DNA, RNA and proteins will be linked with patient outcomes data via web-based tools
CASTLE provides a broad-based, clinically validated panel of biomarkers and partnerships with diagnostic laboratories
• A dynamic biomarker panel is evolving
• Tissue collections will enable reanalysis as new molecular markers and mutations are discovered
CASTLE bridges the gap
• CASTLE provides immediate access to technologies, information and data to treating physicians and community health providers leading to better outcomes for patients via customized treatment – consequently treat the whole person rather than just the disease
• CASTLE will have a registry of tissue like no other in the world, available no only to investigator in the United States, but worldwide.
What happens if you join this study?
You will meet with a lung cancer doctor who is an ALCMI CASTLE study doctor, and members of his or her research team. They will explain the study.
If you agree to participate in the study, the procedures are as follows:
• You will be asked to give samples from a biopsy (a tissue sample from your tumor). You will be asked to participate in this study only if you have already had a biopsy, or are having a planned biopsy or surgery. You will not be asked to have a biopsy or surgery only to qualify for or participate in this study.
• At study entry, you will be asked about your health and cancer history, current medications, smoking history, toxic exposure history, and your family history of cancer. You will also be asked to give about 36 milliliters, or a little more than 7 teaspoons, of blood for testing and research. This visit will take about one hour to complete.
• Every time there are changes in your lung cancer treatments you will be asked to give about 19 milliliters, or almost 4 teaspoons, of blood for research purposes. You will also be asked about your current and recent medications, and any cancer treatments at these visits. Each visit will take about 30 minutes to complete.
• You will be asked to give your study doctor and his or her research team permission to contact you or your family every 3 months and/or if your cancer treatment changes. They will ask you about your health and your treatment.
Alta Bates Summit Medical Center
Contact: Margie Macarewich, RN, MSN
Hoag Memorial Hospital
Newport Beach, California
Contact: Douglas R. Zusman, MD
Lahey Clinic Hospital
Contact: Kathleen Sherman
Clinical Research Associate
Contact: David P. Carbone, MD, PhD
University of California, Davis
Contact: Corinne Turrell
Clinical Trials Navigator
Contact: Grace Loredo
Sr. Clinical Research Coordinator
University of California, San Francisco
San Francisco, California
Contact: Scot Hammond
University of Southern California
Los Angeles, California
Contact: Gina Tse, RN
Protocol Coordinator, 323-865-0514
Correlative science is a term used to show the relationship between molecular biology (i.e. biomarkers such as genes and proteins) and clinical outcomes (i.e. disease progression). This is the promise of personalized medicine.
ALCMI is currently developing a new correlative study enabling longitudinal detection and monitoring of mutations in blood and correlation with clinical outcomes in lung cancer patients. In certain subsets of patients, we will determine whether the existing or acquired resistance mutations can be identified in the blood of patients at study entry and prospectively over time. Further, we will describe the treatment, clinical course and overall clinical outcome in patients with detectable mutations compared to those in which it is not detected.