Extracellular Vesicles and Particles (EVP) as Biomarkers of Recurrence in Non-Small Cell Lung Cancer
1 other identifier
observational
200
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2022
CompletedStudy Start
First participant enrolled
June 14, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
July 3, 2025
July 1, 2025
4 years
June 14, 2022
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
A member of the patient's treatment team, the protocol investigator, or the research team at MSK will identify potential research subjects
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553, United States
Related Links
Biospecimen
bronchial washings
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Jones, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2022
First Posted
June 21, 2022
Study Start
June 14, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
July 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.