Cough Capture as a Portal Into the Lung (CC1)
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ClinicalTrials.gov Identifier: NCT05854563 |
Recruitment Status :
Recruiting
First Posted : May 11, 2023
Last Update Posted : March 18, 2024
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Condition or disease | Intervention/treatment |
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Lung Diseases Lung Cancer Lung Diseases, Obstructive Lung Diseases, Interstitial Lung Inflammation | Other: Observational only, all subjects; measure DNA mutation and proteomic survey. |
Study Type : | Observational |
Estimated Enrollment : | 2000 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Cough Capture as a Portal Into the Lung-ICTR Pilot |
Actual Study Start Date : | March 28, 2023 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2024 |
Group/Cohort | Intervention/treatment |
---|---|
Bronchoscopy subjects, current or former smokers
Bronchoscopy subjects >=21 yo, current or former smokers
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Other: Observational only, all subjects; measure DNA mutation and proteomic survey.
Observational only, all subjects; measure DNA mutation and proteomic survey.
Other Name: Observational study to develop a cough diagnostic |
Bronchoscopy subjects, never smokers
Bronchoscopy subjects >=21 yo, never smokers
|
Other: Observational only, all subjects; measure DNA mutation and proteomic survey.
Observational only, all subjects; measure DNA mutation and proteomic survey.
Other Name: Observational study to develop a cough diagnostic |
- Number of smoker and non-smoker participants demonstrating somatic DNA mutations as evidenced by mutation burden [ Time Frame: Up to 30 minutes for collection of all airway samples ]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
- Aggregate Median Mutation Rate in smoker and non-smoker participants [ Time Frame: Up to 30 minutes for collection of all airway samples ]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.
- Number of smoker and non-smoker participants demonstrating altered protein expression [ Time Frame: Up to 30 minutes for collection of all airway samples ]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.
- Proteomic signature comparison in smoker and non-smoker participants [ Time Frame: Up to 30 minutes for collection of all airway samples ]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.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 21 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
Inclusion Criteria: All consenting subjects with a clinical indication/imminent bronchoscopy.
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05854563
Contact: Ahamefule Okorozo, MBBS | 718-678-1035 | ahamefule.okorozo@einsteinmed.edu | |
Contact: Karen Milian | 718-678-1040 | karen.milian@einsteinmed.edu |
United States, New York | |
Albert Einstein College of Medicine | Recruiting |
Bronx, New York, United States, 10461 | |
Contact: Simon D Spivack, MD 718-678-1040 simon.spivack@einsteinmed.edu | |
Contact: Ahamefue Okorozo, MBBS 718-678-1035 adamefule.okorozo@einsteinmed.edu |
Principal Investigator: | Simon D Spivack, MD | Albert Einstein College of Medicine |
Responsible Party: | Albert Einstein College of Medicine |
ClinicalTrials.gov Identifier: | NCT05854563 |
Other Study ID Numbers: |
2007-407 U01ES029519-01 ( U.S. NIH Grant/Contract ) U01HL145560 ( U.S. NIH Grant/Contract ) R33HL156279 ( U.S. NIH Grant/Contract ) UM1TR004400 ( U.S. NIH Grant/Contract ) |
First Posted: | May 11, 2023 Key Record Dates |
Last Update Posted: | March 18, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Yes, after publication, all IPD can be made available. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | within 6 months of study publication/conclusion |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Lung Diseases Lung Diseases, Obstructive Lung Diseases, Interstitial Inflammation |
Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Infections |