Lung Cancer Clinical Trial
— CC1Official title:
Cough Capture as a Portal Into the Lung-ICTR Pilot
Background: The lung is a privileged organ; blood does not reflect most lung processes well, if at all. Therefore, for population scale diagnostics, the investigator team is developing non-invasive portals to the lung, for eventual early detection/risk assessment and diagnostic purposes. However, large macromolecules are not likely suspended nor readily detected in the breath. In particular, genomic DNA in the breath condensate (EBC) is very sparse, and where present, generally highly fragmented, not readily amenable to sequencing based assessments of DNA somatic mutation burden or distribution. Because gDNA (and protein) is challenging to obtain non-invasively from EBC, the study team considered alternative surrogate lower airway specimens. Cough capture is rarely done, and the investigator team is in the process of optimizing its collection. Importantly, the team will be evaluating how much of coughed material is from saliva contamination. Additionally, analyzing material that is target captured by capturing deep lung extracellular vesicles (EVs) using immobilized CCSP/SFTPC antibodies targeting EVs from distal bronchiole Club and alveolar type 2 cells could circumvent the mouth contamination problem, leaving a non-invasive portal to the deep lung suitable for large molecules, and in turn suitable for myriad epidemiologic and clinical applications. Proposal: The investigator team proposes (Aim 1) to pursue optimizing cough collection, and testing the efficacy and practicality of partitioning cough specimen for deep-lung specific extra-cellular vesicles (EVs). This cough specimen will be compared to that from invasively collected deep lung samples BAL/bronchial brushings, and to the potential contaminating mouthrinse, all from the same individuals. (Aim 2) The study team initially proposes to examine these cough specimens for somatic mutations by SMM bulk sequencing for single nucleotide variation, developed in the Vijg/Maslov labs. Finally, the investigator team will (Aim 3) test all airway specimens (cough, mouthwash and BAL) for lung surrogacy of cough, using proteins known to be specific for lung, as opposed to oral cavity/saliva, in the Sidoli/proteomics core. Impact: The investigator team envisions that the translational impact of non-invasively obtained DNA or protein markers could allow for more rapid acute clinical diagnoses, and facilitate precision prevention and/or early detection of many acute and chronic respiratory disorders, including lung cancer, asthma and COPD, acute and chronic infectious diseases, and indeed systemic disorders of inflammation and metabolism.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 21 Years to 95 Years |
Eligibility | Inclusion Criteria: All consenting subjects with a clinical indication/imminent bronchoscopy. - Inclusion Criteria: - Age: minimum age of 21 years - Gender: Male and Female adults - Ethnicity: All ethnic groups and races. - Subjects undergoing bronchoscopy for diagnostic purposes or therapy. Exclusion Criteria: - Clinical dyspnea or cough precluding comfortable collection of additional cough/mouthwash or bronchoscopy specimens - Bleeding diathesis or known coagulopathy precluding endobronchial brushing (e.g. INR>1.3, PTTr>1.3), thrombocytopenia 3.0, - Unstable angina, Recent myocardial infarction (within 3 months), - Uncontrolled congestive heart failure or severe pulmonary hypertension (mean PAP>75 mmHg). - Other contraindication to clinical-indicated bronchoscopy. |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein College of Medicine | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine | National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Environmental Health Sciences (NIEHS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of smoker and non-smoker participants demonstrating somatic DNA mutations as evidenced by mutation burden | Somatic DNA analysis will be conducted using Single Molecule Mutation sequencing (SMM-seq) to identify mutations in EV-partitioned cough samples. The number will be determined by statistical testing using Fishers Exact Test to determine if there is a nonrandom association between the two variables | Up to 30 minutes for collection of all airway samples | |
Primary | Aggregate Median Mutation Rate in smoker and non-smoker participants | Somatic DNA analysis will be conducted using Single Molecule Mutation sequencing (SMM-seq) to identify mutations in EV-partitioned cough samples. The aggregate median mutation rate (somatic mutation burden) in the cough from the group of smokers, as compared to that of non-smoking individuals, will be determined by statistical T-test. | Up to 30 minutes for collection of all airway samples | |
Primary | Number of smoker and non-smoker participants demonstrating altered protein expression | Proteomic analysis will be conducted via LC-MS on the collected and EV-partitioned cough samples, MW samples, and BAL samples, respectively. To evaluate cough surrogacy for the deep lung (BAL) specimen, Spearman correlations of the most highly expressed 80 proteins among the three specimen types will be compared. The number of participant specimens demonstrating Spearman inter-tissue correlation values in excess of their corresponding threshold (0.3) will be tabulated. | Up to 30 minutes for collection of all airway samples | |
Primary | Proteomic signature comparison in smoker and non-smoker participants | Proteomic analysis will be conducted via LC-MS on the collected and EV-partitioned cough samples, MW samples, and BAL samples, respectively. The proteomic signature of the most highly expressed 80 proteins in each of three specimen types will be compared between the current smoker and the non-smoker participants using PCA. | Up to 30 minutes for collection of all airway samples |
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