Role of Circulating Tumor DNA (ctDNA) From LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation (LIBERTI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03553550|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : July 9, 2018
|Condition or disease||Intervention/treatment|
|Non Small Cell Lung Cancer||Other: biospecimen collection|
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 the patient undergoes 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 your treatment is working, learn if the cancer is coming back, or find drugs that may target the changed tumor cells.
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 NSCLC. Tumor markers may be used to help predict a response to certain cancer treatments and to check how the patiet's type of cancer responds to the treatment.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Role of Circulating Tumor DNA (ctDNA) From LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2024|
- Other: biospecimen collection
Peripheral blood collection Archival tissue collection
- To correlate the presence of ctDNA following complete surgical resection with disease-free survival. [ Time Frame: June, 2023 ]Correlation between ctDNA after surgery and disease-free survival, defined as the time from surgical resection to the earliest event defined as disease recurrence, death or new lung cancer.
- To evaluate the relation between changes in ctDNA during surveillance and tumor relapse [ Time Frame: June, 2023 ]Evaluate the changes in ctDNA after complete resection at pre-specified intervals and correlate the presence of ctDNA with overall survival.
- Overall survival [ Time Frame: June, 2023 ]Evaluate the effect of adjuvant therapy on the ctDNA levels and tumor relapse, ct DNA alterations during the follow-up and concordance between mutations detected in the operative specimens and ct DNA.
Biospecimen Retention: Samples With DNA
Tissue - The participant will be asked to provide a tissue sample collected during a clinically-indicated surgery for NSCLC. This sample will be divided and put on to slides to be seen under a microscope. The slides will be stored at the ALCMI Biorepository for future lung cancer research purposes. The slides may be selected to study circulating tumor cells (cells from the tumors that circulate in the bloodstream) and their patterns.
Peripheral blood - 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. We expect the research testing to consume the entire blood specimen. However, if any residual blood specimen remains, it will be stored at IniVata however, it cannot be used without ALCMI's permission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553550
|Contact: Alicia Sable-Hunt, RN,MBA,CCRAemail@example.com|
|Contact: Richard Erwinfirstname.lastname@example.org|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|Contact: Jade Cunningham, BSN, RN 404-236-8337 Jade.Cunningham@northside.com|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Kimberly Pepin 314-747-8711 email@example.com|
|Principal Investigator:||Daniel Morgensztern, MD||Washington University School of Medicine|