LIBERTI – Liquid Biopsy Study for NSCLC Patients

Daniel Morgensztern, MD

Ramaswamy Govindan, MD

Every type of cancer is associated with changes in genes and protein structure or function in the body known as “biomarkers”. These biomarkers can help diagnose cancer, as well as to track the disease and response to treatment. Over the last 10 years, technology has led to the identification of many cancer biomarkers; the use of cancer biomarkers has become an important part in the treatment and management of cancer.

For solid tumors, biomarker testing is usually done on the tumor tissue from a biopsy or surgery. Although testing tumor tissue provides a lot of information, there are some challenges with the process. First, tumor cells can be different even within small tumors. To overcome this, the pathologist (doctor that examines tumor tissue) needs to test cells from different parts of the tumor. Often, there may not be enough of the tissue to test for biomarkers. In addition, tumor cells change when you undergo treatment and there might be a need to repeat biopsies. Sometimes it may not be possible to repeat a biopsy to study the changes in biomarkers because some patients cannot have a repeat biopsy done safely.

There are many advantages to tracking biomarkers in the blood instead of on tissue. We can study changes in biomarkers more often (because it is a blood draw), and therefore will be able to determine how treatment is working, learn if the cancer is coming back, or find drugs that may target the changed tumor cells.

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Study Purpose
The purpose of this research study is to learn more about changes in cell-free tumor DNA in blood samples, also known as a liquid biopsy, as they relate to treatment and response to treatment. Cell-free tumor DNA is genetic material that is released into your bloodstream from tumor cells as they die. Genes are a unique combination of molecules (called DNA) that are found in all human cells. In some cases, these genes may be changed in cancer and tumor cells. These changes, or tumor markers are substances produced by cancer cells that are found in the blood, body fluids or tissues, and may be made of DNA, RNA, proteins, cells or components of cells. In the future, the “markers” may help doctors decide which treatments could be most beneficial for your type of cancer. Tumor markers may be used to help predict a response to certain cancer treatments and to check how your type of cancer responds to the treatment.

We are working with Inivata, a company that specializing in liquid biopsy. To learn more about Inivata, visit their website at https://www.inivata.com.

What Should You Expect in This Study
The research study has certain requirements that must be met. If you do not meet the requirements, you will not be able to participate in this research study.

If you are eligible for the study, you will work with our study team to complete the following tasks:

You will be asked to provide a tissue sample collected during your surgery for NSCLC.

The tissue sample will be stored at the ALCMI Biorepository for future lung cancer research purposes. Your tissue may be selected to study circulating tumor cells (cells from the tumors that circulate in the bloodstream) and their patterns.

You will be asked to provide between 13-14 blood draws over the course of 5 years. If you leave the study earlier than 5 years, you will provide fewer blood draws.

Blood draw timepoints:

  • Before your surgery.
  • 2-3 days after your surgery.
  • Approximately 4-6 weeks after your surgery at your post-surgery checkup.
  • 6 months after your surgery.
  • Every 6 months after your surgery up to 5 years unless your cancer returns.

The blood will be sent to a company named, Inivata, to study the changes in circulating tumor cells (cells from the tumors that circulate in the bloodstream) as well as DNA (parts of the cell that carry genetic information) most often seen in NSCLC.

You will not be told the results of research testing performed on your tissue or blood specimen.

How To Participate
Individuals being treated at a participating institution may join the study. For a list of participating centers, visit clinicaltrials.gov (here is the hyperlink to the LIBERTI study https://clinicaltrials.gov/ct2/show/NCT03553550?term=liberti&rank=2).

  1. The first step is to complete the Contact Form. A member of our study team will contact you to discuss your interest in the study.
  2. The study team will review the study requirements and, if you meet the pre-screening requirements, you will be provided access to a participating institution.
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