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NCT05424029 Clinical Trial

Extracellular Vesicles and Particles (EVP) as Biomarkers of Recurrence in Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title:
Extracellular Vesicles and Particles (EVP) as Biomarkers of Recurrence in Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05424029
Other study ID # 22-155
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 14, 2022
Est. completion date June 2024

Study information
Verified date September 2023
Source Memorial Sloan Kettering Cancer Center
Contact David Jones, MD
Phone 212-639-6428
Email jonesd2@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to find out if fluid rinsed from peoples' airways (bronchial washing samples) during routine surgery to remove (resect) their non-small cell lung cancer (NSCLC) tumors contains enough vesicles to do testing that may help the researchers learn more about their NSCLC.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients = 18 years of age undergoing consideration of surgical resection, including lobar resections, sublobar resections, and pneumonectomies, for primary lung cancer will be eligible. - Patients with previously resected disease and/or previous radiation therapy will be considered on a case by case basis. Exclusion Criteria: - Patients with active infection or pneumonia which may impact exosome makeup - Additionally, if at the discretion of the operating surgeon, obtaining bronchial washings would lead to undue morbidity, the patient would be excluded and replaced

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Consent Only) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk - Commack (Consent Only) Commack New York
United States Memorial Sloan Kettering Westchester (Consent Only) Harrison New York
United States Memorial Sloan Kettering Monmouth (Consent Only) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Consent Only) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Consent Only) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary to isolate exosomes from bronchial washings every patient from whom the essential specimens have been acquired will be evaluated to determine if more than 100,000 microvesicles can be isolated for exosome purification day 1
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