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Trial record 1 of 1 for:    NCT 03553550
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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 : Terminated (Enrollment futility)
First Posted : June 12, 2018
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Addario Lung Cancer Medical Institute

Tracking Information
First Submitted Date May 30, 2018
First Posted Date June 12, 2018
Last Update Posted Date November 19, 2020
Actual Study Start Date June 1, 2018
Actual Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 5, 2018)
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.
Original Primary Outcome Measures
 (submitted: May 30, 2018)
To correlate the presence of ctDNA following complete surgical resection with disease-free survival. [ Time Frame: June, 2023 ]
Change History
Current Secondary Outcome Measures
 (submitted: July 5, 2018)
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.
Original Secondary Outcome Measures
 (submitted: May 30, 2018)
To evaluate the relation between changes in ctDNA during surveillance and tumor relapse [ Time Frame: June, 2023 ]
Current Other Pre-specified Outcome Measures
 (submitted: July 5, 2018)
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.
Original Other Pre-specified Outcome Measures
 (submitted: May 30, 2018)
Overall survival [ Time Frame: June, 2023 ]
 
Descriptive Information
Brief Title Role of Circulating Tumor DNA (ctDNA) From LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation
Official Title Role of Circulating Tumor DNA (ctDNA) From LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation
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.
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

Sampling Method Probability Sample
Study Population Adults diagnosed with Stage IB, II or IIIA NSCLC that have a planned surgery to treat their cancer.
Condition Non Small Cell Lung Cancer
Intervention Other: biospecimen collection
Peripheral blood collection Archival tissue collection
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: November 18, 2020)
38
Original Estimated Enrollment
 (submitted: May 30, 2018)
500
Actual Study Completion Date November 15, 2020
Actual Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03553550
Other Study ID Numbers ALCMI-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Addario Lung Cancer Medical Institute
Study Sponsor Addario Lung Cancer Medical Institute
Collaborators Not Provided
Investigators
Principal Investigator: Daniel Morgensztern, MD Washington University School of Medicine
PRS Account Addario Lung Cancer Medical Institute
Verification Date November 2020