How will the LiFT UP Study help me or my family?
While we do not know if taking part in this study will directly benefit you, this study aims to help researchers learn information that could help people with Li-Fraumeni syndrome (LFS) or TP53 gene changes in the future. We hope that this study will improve our ability to predict cancer risks for each person with LFS and/or other TP53 changes, and to offer better options for cancer prevention, early detection, and treatment in the future.
As part of the study, you will be asked how you prefer to receive research results if any are found that may have meaning for your health and/or the health of your family. It is unlikely that there will be research results returned as part of this study. However, if there are, we will try to contact you based on your preference.
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 research study.
If you have a TP53 variant and your doctor has asked you to have a skin biopsy, there may be a charge. If your doctor thinks the biopsy is necessary for your care, it can be billed to your insurance. If the skin biopsy is for this research only, we will help to cover the cost.
Will this study cover the costs of cancer screening?
Cancer screening tests may be recommended based on your genetic test result. 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 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. We also take additional care to protect your personal information. Study data is in a database protected by a password and is within the “firewall” created by our institutions (City of Hope and Dana-Farber Cancer Institute). The database is on a secure server that only study staff can get to. Hard copies of the study data will be kept in locked file cabinets that only study staff can get to.
Can I leave the LiFT UP Study after I have joined?
Yes, participation is always optional. 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.
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 in the consent form, some data must be deposited in government databases but without your personal identifying information.
How can I submit my medical records as part of this study?
Having access to your medical records allows us to better understand your TP53 mutation.
You or your healthcare provider may give your records to our research team in a few different ways:
- You can directly upload your records through this form
- You can email your records to our team at liftupstudy@dfci.harvard.edu or liftup@coh.org
- You can mail your records to us. Please call our team at 617-632-4795 or 626-218-1572 to get the best mailing address. In some cases, we may be able to provide you with a prepaid envelope that you can use to mail your records in.
- You can fax your records to us. Please call our team at 617-632-4795 or 626-218-1572 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 you to coordinate your blood draw during a time that is convenient for you. You will not be responsible for the shipping or handling of the blood specimen.
Our study team will cover all costs related to your blood draw for this study.
If you have any questions or concerns about the blood sample, please contact us.
Alternatively, we may be able to coordinate your blood sample collection with one of your medical visits when a blood draw is already scheduled.
How can I give a saliva sample as part of this study?
Our study team can send a saliva sample collection kit directly to you at no cost.
When giving the saliva sample, we ask that you do not eat, drink, or chew gum for 1 hour prior to the sample collection.
If you have any questions or concerns while collecting your sample, please contact us.
How can I give an eyebrow pluck sample as part of this study?
Our study team can send an eyebrow hair collection kit directly to you at no cost. This kit will include:
- Alcohol wipe
- Sterilized tweezers
- A sterilized tube filled with a preservation solution
- Safeguard shipping container and plastic bag
- Prepaid shipping envelope
- Sample tracking form for you to complete
When collecting your eyebrow hair sample, please follow these directions:
- Sterilize your eyebrows by wiping them with the provided alcohol wipe
- Use the provided sterilized tweezers to pluck 15-20 eyebrow hairs
- As you pluck, visually inspect each hair to see if you are getting good quality bulbs. A good quality bulb means you should be able to see a thick black or white bulb on the end of each pluck.
- Place all 15-20 hairs into the provided tube with the preservation solution. Make sure to securely tighten the top of the tube once all hairs have been collected.
- Complete the sample tracking form, making sure to fill out your name, your date of birth, and the date that you collected your hair sample.
- Please ship the sample within 1-2 days of your pluck.
When sending your sample back to us, please follow these directions:
- Place the tube with your hair into the foam insert cutout
- Close the plastic specimen container over the specimen insert. Push down on each corner to insure the container is fully closed.
- Insert the snap-lock plastic case into the plastic bag and seal completely
- Place the snap-lock case and plastic bag and your sample tracking form into the prepaid shipping envelope
- Drop off the shipping envelope at your nearest postal service.
A copy of these instructions will also be sent to you with the collection kit. If you have any questions or concerns while collecting your sample, please contact us. We are happy to help you through this process!
How long will my samples from this study be stored?
Indefinitely, but if at any point you decide to withdraw from the study, your data and samples are marked for withdrawal and are no longer used.
If you decide to withdraw from this study, it may not be possible to remove all samples and data 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?
Most tests performed on samples in research studies are only for research and have no clear meaning for health care. We are glad to share the overall results of the study, but we do not expect to have individual results for you. We hope to learn information in the study that will permit more accurate individual prediction of cancer risk. If that happens, we may be able to share your specific information with you, or at least to advise you and your physicians how to get that information for you based on a new blood specimen.
If a research result may have meaning for your health or your family’s health, we would ask you to clinically confirm your results outside of the research study. Our study team can provide you with resources to obtain clinical confirmation testing.
What resources are available to help me understand my genetic testing result?
If you have questions about your genetic test results, we encourage you to speak with the healthcare provider who ordered the test or to reach out to either of our study sites below:
City of Hope Cancer Screening and Prevention Program
626-218-1572
Dana-Farber Cancer Institute Li-Fraumeni and TP53 Center
617-632-4795
What support organizations are available to me and my family?
LFSA: www.lfsassociation.org
855-239-LFSA (5372)
Living LFS: www.livinglfs.org
1-844-LFS-CALL (1-844-537-2255)
FORCE: www.facingourrisk.org
866-288-RISK (7475)
Bright Pink: www.brightpink.org