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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 98119 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| NCI-2019-05682 | Other Identifier | NCI | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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The PI is requesting this study to be closed due to the departure of the Co-PI who is an integral part of the study.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.
Primary Objective:
• To quantify the intra-person variability of concentrations of TGF-β1, IL-6, IL-1α, and IL-10 measured in exhaled breath condensate.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exhaled Breath Analysis | Experimental | Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exhaled Breath Collection | Other | Exhaled breath condensate (EBC) and exhaled breath volatiles (EBV) samples will be obtained over 5-10 minutes using a one-time use R-tube apparatus. |
| Measure | Description | Time Frame |
|---|---|---|
| Variability of Biomarkers | Concentrations of TGF-β1, IL-6, IL-1α, and IL-10 (ng/mL) will be measured in exhaled breath condensate at baseline, at 2 weeks and after chemotherapy start and 6 weeks after chemotherapy start (the end of chemotherapy) and 1 month after completion of chemotherapy using a 2-tailed alpha of 0.05 with detectable standard deviation units from baseline to post treatment. | At baseline and one month after completion of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT | TGF-β1, IL-6, IL-1α, and IL-10 (ng/mL) measured in exhaled breath condensate to compare mean change levels from (baseline), at 2 weeks after CRT start, 6-weeks after CRT start (the end of CRT), and 1 month after completion of chemotherapy using t-tests comparing mean change levels in each marker. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Farris, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exhaled Breath Analysis | Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes. Exhaled Breath Collection: Exhaled breath condensate (EBC) and exhaled breath volatiles (EBV) samples will be obtained over 5-10 minutes using a one-time use R-tube apparatus. Blood sample: Blood samples collected simultaneously with routine standard of care blood draws. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exhaled Breath Analysis | Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes. Exhaled Breath Collection: Exhaled breath condensate (EBC) and exhaled breath volatiles (EBV) samples will be obtained over 5-10 minutes using a one-time use R-tube apparatus. Blood sample: Blood samples collected simultaneously with routine standard of care blood draws. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Variability of Biomarkers | Concentrations of TGF-β1, IL-6, IL-1α, and IL-10 (ng/mL) will be measured in exhaled breath condensate at baseline, at 2 weeks and after chemotherapy start and 6 weeks after chemotherapy start (the end of chemotherapy) and 1 month after completion of chemotherapy using a 2-tailed alpha of 0.05 with detectable standard deviation units from baseline to post treatment. | 9 have data at baseline; 6 have data at 1 month post CRT (chemo-radiation treatment) | Posted | Mean | Standard Deviation | ng/mL | At baseline and one month after completion of chemotherapy |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exhaled Breath Analysis | Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes. Exhaled Breath Collection: Exhaled breath condensate (EBC) and exhaled breath volatiles (EBV) samples will be obtained over 5-10 minutes using a one-time use R-tube apparatus. Blood sample: Blood samples collected simultaneously with routine standard of care blood draws. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Wake Forest Baptist Comprehensive Cancer Center | 336-716-4760 | jkettler@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2021 | Aug 8, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2021 | May 2, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood sample | Other | Blood samples collected simultaneously with routine standard of care blood draws. |
|
| One month after completion of chemotherapy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT | TGF-β1, IL-6, IL-1α, and IL-10 (ng/mL) measured in exhaled breath condensate to compare mean change levels from (baseline), at 2 weeks after CRT start, 6-weeks after CRT start (the end of CRT), and 1 month after completion of chemotherapy using t-tests comparing mean change levels in each marker. | 6 participants who had relevant data at both required time points | Posted | Mean | Standard Deviation | ng/mL | One month after completion of chemotherapy |
|
|
|
| 0 |
| 16 |
| 1 |
| 16 |
| 5 |
| 16 |
| Cardiac arrest | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Gastrointestional hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment | Heartburn |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Noncardiac chest pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
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| D002283 |
| Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Title | Measurements |
|---|---|
|
| IL-1a mean diff |
|