MENUFrequently Asked Questions the Judith Tam ALK Lung Cancer Research Initiative
Q: Who is eligible for the study?
A: Anyone, at least 18 years or older, with a lung cancer diagnosis (preferably, but not necessarily, ALK-positive non-small cell lung cancer) or a suspected lung cancer diagnosis (such as a lung nodule) is eligible to participate. This includes individuals with any treatment status (i.e. pre, post, or current chemotherapies/immunotherapies) and any clinical interventions (i.e. fluid removal, surgical resection). You do not have to have disease progression to participate.
Q: Can I participate even if I do not live in Michigan?
A: Non U-M participants are able and welcome to enroll in the study if one meets eligibility criteria. This includes those living outside of Michigan and outside of the USA. If you are screened and accepted to the study, we will work with your institution (please refer to Q11 regarding MTA – Material Transfer Agreement) to receive the necessary medical information and samples.
Q: Will I need to travel to U-M to participate in the study?
A: While we are always happy to welcome our participants to the University of Michigan campus, this is not a requirement to participate in the study. If your institution is able to accommodate, we will work directly with them to coordinate any research sample collections and have them shipped to U-M via an MTA (see Q11). If you choose to travel to U-M for any procedures, please first check with your insurance provider to find out if you have coverage at the University of Michigan as the initiative is unable to assist with costs associated with your medical care. This applies to participants who live inside and outside of the United States.
Q: I am a U-M patient. How can I get involved?
A: To participate, email [email protected] with your upcoming appointment and the physician you will be seeing. If you are scheduled for a surgery, biopsy, or fluid removal, you will be asked to sign an informed consent before we may receive any samples.
Q: I am not a U-M patient. How can I get involved?
A: If you are eligible for the study and cannot travel to U-M for an initial assessment or second opinion, please email [email protected] with your contact information and any upcoming procedures. We will reach out for enrollment with an intake survey and a subsequent screening interview. Please be advised that our team may need time to set up the appropriate agreements with your institution to send samples for research. If possible, please reach out at least a month prior to any upcoming procedures.
Q: What kind of samples are being collected?
A: There are 3 main types of samples collected: fluid (pleural, ascites, cerebrospinal, etc.), blood and tissue. These samples are typically collected during clinically indicated blood draws and procedures, such as paracentesis, thoracentesis, and surgical resections.
Q: During surgery, does the study receive tissue that would be used otherwise be used for diagnostic purposes?
A: The tissue we receive does not have any impact on whether you may receive the necessary tests for diagnostic purposes. There would be no interference with your clinical care; clinical needs always supersede research activities. As such, there is also no guarantee of sufficient tissue for research purposes.
Q: How much blood do you need for research?
A: We may request up to 50 cc (50 mL, about 3 tablespoons) of blood periodically for research activities.
Q: How much tissue do you need for research?
A: We will accept and process a tissue sample as small as a grain of rice. However, the larger the sample, the far greater chances of successful drug testing through various models.
Q: Can I mail you my sample directly?
A: Ideally, your institution would mail the sample to U-M. However, if they are unable to send a blood sample, we may accept it from you. Please check with your institution first to see if there are any regulatory restrictions that might prevent you from leaving with the blood sample. To ensure it arrives the next morning, drop off the properly packaged sample at a FedEx location on the same day it is drawn. Before a tissue/fluid sample is sent to U-M, an agreement should be established between your oncologic institution and U-M. For regulatory compliance, your institution will be responsible for sending tissue and/or fluid samples.
Q: What is an MTA?
A: A material transfer agreement (MTA) is a contract governing the transmission of research samples between two institutions and is a vital step to ensure proper protocol. We are currently able to accept samples from institutions with which we have an established MTA. If your institution does not have an MTA with U-M, we will work with them to set up an MTA, or gift agreement, prior to sample procurement. Please note that establishing an MTA can take a significant amount of time, and not all attempts will necessarily be successful.
Q: How much does it cost me to participate in the study?
A: There is no additional cost to patients for participation in the Judith Tam ALK Lung Cancer Research Initiative as the blood draws and other sample collections occur during a clinically indicated visit. What this means is that all the procedures are done as part of your clinical care, and therefore these costs would be billed to your insurance the same as you would have incurred if not participating with our research. The Initiative will cover research-related costs associated with transporting, packaging, testing, and otherwise handling your samples. If you have any questions or concerns, please reach out early on and the Initiative can help address them.
Q: I had a previous surgery and have archived tissue. Will this work for your study?
A: We are happy to accept archival tissue. However, there are limitations on what can be done with the sample. Fresh tissue works best for the successful experimentation (organoid drug testing, PDX generation, etc.).
Q: If I have blood drawn outside of my institution (Quest or LabCorp) can you work with them to receive my sample?
A: We understand that many patients receive blood draws outside of their institution for convenience. However, while we are able to receive blood from Quest or LabCorp, the cost of the draw would be your responsibility. If you would like to have blood drawn for research at an independent lab, please note that the associated costs would be your responsibility. If possible, please schedule your blood draw at an institution where an MTA is established and inform us so we may coordinate shipping and receiving the sample at U-M.
Q: My ALK mutational status has changed (either a loss of ALK mutation or a new mutation detected). Are you still interested in my samples?
A: We are actively attempting to understand the drivers of progression for patients with changes or loss of the ALK mutation. As such, we are happy to accept any samples from you even if there is a change in your mutational status.
Q: : Will I or will my healthcare team receive results from any of the tests that are done on my samples?
A: We are working tirelessly with regulatory and governing bodies to allow us to be able to return results. However, as it currently stands, we are unable to return any results to participants or their healthcare team, whether formally or informally. We will provide updates as the status hopefully changes.