Is this study open to international participants?
At this time, the study is only open to those who currently reside in the United States. We are hoping to expand to other areas in the future; please check back periodically for these updates.
What are the benefits of participating in the Young Lung Cancer Study?
While we do not know if taking part in this study will directly benefit you, our study aims to help researchers gain information that could help people diagnosed with lung cancer at a young age. We hope that this study will improve our ability to predict cancer risks in people 45 and younger, and possibly to offer better options for cancer prevention, early detection, and future treatment.
As part of the study, you will be asked how you prefer to receive testing results if any are found that may have meaning for your health and/or the health of your family. If there are, our study team and genetic counselors will contact you based on your communication preferences.
Is there any cost to me for participating?
There is no cost to be in this study. You will not be charged for blood draws that occur as part of this study.
Any additional testing or procedures necessary for your care can be billed to your insurance as part of your standard or routine clinical care.
Does this study cover the costs of cancer screening?
Cancer screening tests may be recommended based on your genetic testing results. Cancer screening costs are not covered by this study, and coverage for these services (such as mammogram, colonoscopy, or whole-body MRI screening) may depend on your insurance. Our study team can provide information on how to access screening. Please contact us for more information.
How will you protect my privacy and personal information?
A federal law, called HIPAA, protects your medical information. In addition, we take the following steps to protect your personal information:
- Study data is in a database protected by a password and is stored inside the Dana-Farber Cancer Institute firewall.
- The database is on a secure server that only study staff can access.
- Hard copies of any study data are kept in locked file cabinets that only study staff can access.
Who has access to my genetic data?
Our study team will have access to your genetic data, which will be stored in password-protected files. As with the consent form, some data must be deposited in government databases, but without any personally identifying information.
Can I leave the Young Lung Study after I have joined?
Yes, participation is always optional, so you can leave the study at any time. Please contact us if you want to leave the study, so we can make sure to address any concerns you may have.
How do I submit my medical records as part of this study?
Having access to your medical records allows us to better understand your lung cancer diagnosis.
You or your healthcare provider may submit your records to our research team in a few different ways:
- Directly upload your records through a secure web portal (a link will be sent to you).
- Email your records to our team at younglungstudy@dfci.harvard.edu.
- Mail hard copies of your records to us. Please email our team at younglungstudy@dfci.harvard.edu to get the best mailing address. In some cases, we may be able to provide an envelope with pre-paid postage.
- Fax your records to us. Please email our team at younglungstudy@dfci.harvard.edu to get the best fax number.
If you are having a hard time getting access to your medical records or are having trouble sending your medical records to our team, please contact us.
How can I give a blood sample as part of this study?
You may give a blood sample at your convenience by using our mobile phlebotomy option. If you use this option, our study team will send you a kit with the required tubes for the study.
Once you have the kit, a member of the Exam One Mobile Phlebotomy team will reach out to schedule your blood draw at a time that is convenient for you. You will not be responsible for the shipping or handling of the blood specimen.
If you have any questions or concerns about the blood sample, please contact our team.
If you prefer not to use mobile phlebotomy, we may also be able to coordinate your blood sample collection with one of your medical visits when a blood draw is already scheduled.
Our team will cover all costs related to your blood draw for this study.
How long will my samples from this study be stored?
Study samples are stored indefinitely. But, if at any point you decide to withdraw from the study, your data and samples are marked for withdrawal and no longer used.
If you decide to withdraw from this study, it may not be possible to remove all data and samples that have already been submitted to a database or biobank. However, this information will be anonymized (all identifying information removed), and researchers will not be able to connect any results back to you.
Will I receive results from this study?
If you choose to participate in the clinical genetic testing portion of this study, and you choose to be informed of the results from this testing, you will receive results that indicate whether you carry any genetic changes that may raise your risk for developing certain cancers. If there is a positive result, a genetic counselor from the study will contact you and explain the results in more detail, along with options to receive further counseling. If you choose not to participate in this portion of the study, or choose not to know the results of this portion of the study, these results will not be returned to you.
We will also perform research (exploratory) genetic testing as part of the study and are glad to share the overall results, but we do not expect to have individual results for you. Most tests performed on samples in research studies are for research only and have no clear relevance to a participant’s current health care.
What support organizations are available to me?
In addition to the resources affiliated with Dana-Farber, Massachusetts General, and Beth Israel Deaconness Medical Centers, there are many patient advocacy and informational resources available online. These include:
Addario Lung Cancer Medical Institute (ALCMI)
Epidemiology of Young Lung Cancer Study
GO2 Foundation for Lung Cancer
LUNGevity Foundation
EGFR Lung Cancer Resisters
ALK Positive
The ROS1ders
RET positive
What is the difference between “germline” and “somatic”? What about “genetic” and “genomic”?
These terms can be confusing. The term “genetic” can be used in many contexts, and typically is a broad term referring to anything pertaining to genes. Genes are molecules made of DNA that code for instructions to make proteins. Certain proteins then take part in regulating cell growth, division, and replication. A mutation (abnormal change) in a gene can cause dysregulation of these important proteins, contributing to tumor growth and cancer development . “Genomic” refers to the entire collection of genes in the body (about 20,000), which we call the “genome”. “Germline” refers to inherited mutations (passed down at birth) and “somatic” refers to acquired mutations, that happen over the course of a person’s lifetime. Germline genetic mutations are typically inherited at birth from one or both parents, are present in every cell in the body, detectable in saliva and blood, and can be passed on to the next generation. Germline genetic mutations in cancer predisposition genes make certain cancers much more likely to occur in a person’s lifetime compared to cancer risks in people without the mutations. In contrast, somatic genetic mutations happen after birth, over the course of a person’s lifetime and are not passed down. Somatic mutations do not occur in every cell in the body, but only in some cells (such as in tumors), and accumulation of somatic mutations over time can lead to cancer. Examples of these somatic changes that are thought to “drive” lung cancer formation are mutations in genes such as EGFR, KRAS, HER2, MET, and BRAF, or rearrangements (also called fusions) in genes such as ALK, ROS1, and RET. This study is investigating the interaction of germline (hereditary) and somatic (tumor) genetic mutations in the development of lung cancer in younger patients.
For more information on this and Genetics see germline-vs-somatic or watch this video.
Why doesn’t the mutation in my tumor (for example, EGFR mutation or ALK rearrangement) appear on my genetic testing report from this study?
The genetic testing performed as part of the Young Lung study (called germline multi-gene panel testing) uses a blood sample for DNA sequencing, which detects only the genetic mutations that are inherited (“germline”). These mutations are present in blood cells and other cells of the body. While it is true that other types of genetic tests (often called “liquid biopsy” or “ctDNA”) are able to detect circulating DNA from the tumor that is “shed” into the bloodstream, germline genetic testing does not. Therefore, any mutations found in tumor cells will not usually be detected using this germline testing. By contrast, genetic sequencing that is performed on a tumor sample detects mutations present in the tumor (cancer cells) only. This somatic (tumor) testing may report mutations that are inherited, or “germline”, and present in every cell in the body (including the tumor), but often do not. It is important to understand that germline and somatic testing should not replace one another. Each of these tests have unique purposes and should be discussed with your oncologist.
