Frequently Asked Questions the Judith Tam ALK Lung Cancer Research Initiative

Q: Who is eligible for the study?

A: Any patient, 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 patients with any treatment status (i.e. pre, post, or current chemotherapies/immunotherapies) and any clinical interventions (ex: 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 patients are able and welcome to participate. This includes patients living outside Michigan and outside the USA. If you are screened and accepted to the study, we will work with your institution to receive the necessary medical information and samples.

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.

Q: What kind of samples are being collected?

A: There are 3 main types of samples collected: fluid (pleural and ascites samples), 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 for my labs?

A: The tissue we receive does not have any impact on whether you may receive the necessary labs. 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: Ideally, we receive 30 cc (30 mL, about 2 tablespoons) of blood 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: While we are currently seeking approval for participants to send their blood samples to UM, unfortunately, we are unable to receive samples directly from patients at this time. Before samples can be sent to U-M, we must establish a material transfer agreement (MTA) between your oncologic institution and U-M. This is applicable for all sample types including fluid, tissue and blood.

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 prior to sample procurement.

Q: How much does it cost me to participate in the study?

A: There is no cost to patients for participation in the Judith Tam ALK Lung Cancer Research Initiative. We will cover any costs associated with transporting, packaging, and otherwise handling your samples. There is no additional cost during your blood draw visits or surgical procedures. However, please note that any travel and parking costs would be the patient’s responsibility.

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 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, we are currently unable to receive blood from Quest or LabCorp. 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.