Liquid Biopsy for Early Non-small Lung Cancer Detection
NCT ID: NCT05462795
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
171 participants
OBSERVATIONAL
2022-08-02
2024-03-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Indeterminate pulmonary nodule study cohort
Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy
Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule
10 cc of blood is collected at one time point, which is prior to biopsy procedure
Known lung cancer for surgical resection study cohort
Patients with known non-small cell lung cancer who will have surgical resection for treatment
Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection
10 cc of blood is collected at three time points: 1) before surgery; 2) 4-6 weeks post surgery; and 3) 6 months post surgery
Healthy volunteer cohort
Healthy volunteers with a) no current diagnosis of cancer; b) no history of cancer over the last 5 years; and c) no existing known benign lung disease that is currently requiring treatment with medication.
Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer
10 cc of blood is collected at one time point
Benign lung disease cohort
Patients with the following categories of benign lung disease:
* COPD/emphysema
* Granulomatous infection
* Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.
Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease
30 cc of blood is collected at one time point
Interventions
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Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule
10 cc of blood is collected at one time point, which is prior to biopsy procedure
Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection
10 cc of blood is collected at three time points: 1) before surgery; 2) 4-6 weeks post surgery; and 3) 6 months post surgery
Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer
10 cc of blood is collected at one time point
Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease
30 cc of blood is collected at one time point
Eligibility Criteria
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Exclusion Criteria
Healthy volunteer cohort
Benign lung disease cohort
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Linda Garland, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Other Identifiers
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2107020697
Identifier Type: -
Identifier Source: org_study_id