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

NCT03553550 | Terminated

• 1 other identifier: ALCMI-010
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 6

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To correlate the presence of ctDNA following complete surgical resection with disease-free survival.

  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.

  June, 2023

Secondary Outcomes (1)

• To evaluate the relation between changes in ctDNA during surveillance and tumor relapse

  June, 2023

Other Outcomes (1)

• Overall survival

  June, 2023

Interventions

biospecimen collection OTHER

Peripheral blood collection Archival tissue collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults diagnosed with Stage IB, II or IIIA NSCLC that have a planned surgery to treat their cancer.

You may qualify if:

• Male or female aged 18 years and over
• Planned surgical resection of NSCLC, stage IB ≥ 4 cm, II or IIIA according to the 8th edition of TNM classification16.
• 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.
• 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.
• 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.
• Patients with positive margins and those requiring adjuvant radiation therapy are eligible.
• Patients with a secondary malignancy that was treated with curative intent and without evidence of relapse for at least 5 years.
• Willingness to undergo all study collection procedures and follow up.
• Provision of written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Addario Lung Cancer Medical Institute: lead

Study Sites (6)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

St. Louis Cancer Care

Bridgeton, Missouri, 63044, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel Morgensztern, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 12, 2018
• Study Start: June 1, 2018
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)