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Role of Circulating Tumor DNA (ctDNA) From LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation (LIBERTI)

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ClinicalTrials.gov Identifier: NCT03553550
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Addario Lung Cancer Medical Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Other: biospecimen collection

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lung Cancer


Intervention Details:
  • Other: biospecimen collection
    Peripheral blood collection Archival tissue collection


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults diagnosed with Stage IB, II or IIIA NSCLC that have a planned surgery to treat their cancer.
Criteria

Inclusion Criteria:

  1. Male or female aged 18 years and over
  2. Planned surgical resection of NSCLC, stage IB ≥ 4 cm, II or IIIA according to the 8th edition of TNM classification16.

    1. Cohort #1: Neoadjuvant Therapy - For patients who will receive neoadjuvant therapy, enrollment occurs prior to the initiation of treatment. Patients undergoing neoadjuvant therapy who achieved tumor reduction, are eligible based on baseline radiographic staging.
    2. Cohort #2: Pre-Surgery - For patients identified prior to planned surgical resection, enrollment occurs within 30 days of the planned surgery. Eligibility is based on surgical pathology.
    3. Cohort #3: Post-Surgery - For patients identified post-surgical resection, enrollment occurs prior to the initiation of adjuvant therapy. Eligibility is based on surgical pathology.
  3. Patients with positive margins and those requiring adjuvant radiation therapy are eligible.
  4. Patients with a secondary malignancy that was treated with curative intent and without evidence of relapse for at least 5 years.
  5. Willingness to undergo all study collection procedures and follow up.
  6. Provision of written informed consent

Exclusion Criteria:

  1. Male or female aged less than 18 years
  2. NSCLC disease other than stated above
  3. Patients with a secondary malignancy that was not treated with curative intent or has had a disease relapse in the past 5 years.
  4. Unwilling to undergo all study collection procedures and follow up.
  5. Unable or unwilling to provide consent.

Information from the National Library of Medicine

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


Contacts
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Contact: Alicia Sable-Hunt, RN,MBA,CCRA 203-768-9733 asable-hunt@alcmi.net
Contact: Richard Erwin 284-444-2181 rerwin@alcmi.net

Locations
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United States, California
Orange Coast Memorial Medical Center Recruiting
Fountain Valley, California, United States, 92708
Contact: Javier Zuniga    714-378-7496    jzuniga@memorialcare.org   
Principal Investigator: Linda Chan, MD         
Saddleback Memorial Medical Center Recruiting
Laguna Hills, California, United States, 92653
Contact: Javier Zuniga    714-378-7496    jzuniga@memorialcare.org   
Principal Investigator: Linda Chan, MD         
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Javier Zuniga    714-378-7496    jzuniga@memorialcare.org   
Principal Investigator: Linda Chan, MD         
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Jade Cunningham, BSN, RN    404-236-8337    Jade.Cunningham@northside.com   
United States, Missouri
St. Louis Cancer Care Recruiting
Bridgeton, Missouri, United States, 63044
Contact: Kelli Martin, RN, CCRC    314-291-3312    KMartin@stlouiscancercare.com   
Principal Investigator: Juan D Cuevas, MD         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kimberly Pepin    314-747-8711    kpepin@wustl.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kathy Taylor    615-936-2256      
Principal Investigator: Pierre Massion, MD         
Sponsors and Collaborators
Addario Lung Cancer Medical Institute
Investigators
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Principal Investigator: Daniel Morgensztern, MD Washington University School of Medicine

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Responsible Party: Addario Lung Cancer Medical Institute
ClinicalTrials.gov Identifier: NCT03553550     History of Changes
Other Study ID Numbers: ALCMI-010
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no IPD plan created as no individual participate data will be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases