This study aims to find out if fluid rinsed from airways (bronchial washing samples) during routine surgery to remove (resect) tumors contains enough vesicles to do testing in patients with non-small cell lung cancer. Vesicles (exosomes) are tiny sacs that form inside cells, including cancer cells, and they contain some of the cells’ genetic material (deoxyribonucleic acid [DNA] and ribonucleic acid [RNA]) and other proteins. When vesicles are released from one cell and absorbed by a distant cell, they can affect the second cell’s behavior. This study may help researchers learn how isolated exosomes from bronchial washings may determine how patients with non-small cell lung cancer undergoing surgical resection may respond to treatment and how their cancer might spread to other location in the body (metastasize).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05424029.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: David R. Jones
Phone: 212-639-6428
PRIMARY OBJECTIVE:
I. Isolate exosomes from bronchial washings of patients undergoing surgical resection for non-small cell lung cancer in both cancerous and non-cancerous lobes and assess the proportion of patients for whom more than 100,000 microvesicles can be obtained for exosome isolation and purification.
SECONDARY OBJECTIVES:
I. Evaluate bronchial washing exosomes for exosome quantification and exosome morphology.
II. Evaluate exosome biomolecule (protein, DNA, RNA, micro [mi]RNA) content through protein quantification and analysis and DNA and RNA sequencing.
III. Assess differences in exosome profiles from bronchial washings exosomes obtained from lung tumor and non-cancerous lobes, using bronchial washings obtained from a noncancerous, preferably contralateral lobe as a comparison control.
EXPLORATORY OBJECTIVES:
I. Assess relationship between exosome profiles and clinicopathologic and genomic features of the primary tumor.
II. Assess relationship between exosome profiles and primary lung cancer recurrence.
III. Assess differences in exosome profiles from bronchial washing exosomes obtained before neoadjuvant treatment and at the time of surgery.
OUTLINE: This is an observational study.
Patients undergo bronchial washing for collection of bronchial washing samples during standard of care surgery. Patients’ medical charts are also reviewed.
After study completion, patients are followed for 30 days.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorDavid R. Jones
