Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
NCT ID: NCT04063501
Last Updated: 2025-12-02
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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RECRUITING
48 participants
OBSERVATIONAL
2021-02-09
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Advanced stage unresectable Non-Small Cell Lung Cancer
Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy)
Bronchoscopy
The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways
Research Procedures
electrocardiogram, blood work (CBC, chemistry, coagulation profile and liver function tests, pregnancy test if applicable), X-ray and pulmonary function (spirometry) testing, and provide the patient with a stool collection kit.
Interventions
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Bronchoscopy
The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways
Research Procedures
electrocardiogram, blood work (CBC, chemistry, coagulation profile and liver function tests, pregnancy test if applicable), X-ray and pulmonary function (spirometry) testing, and provide the patient with a stool collection kit.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Brain metastasis (as evaluated by MRI obtained as part of standard of care staging evaluation)
* FEV1\<50% predicted
* Cardiovascular disease (defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure)
* Renal disease
* Coagulopathy
* Liver disease
18 Years
100 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Leopoldo N Segal, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
New York Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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N
Role: primary
Other Identifiers
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18-01845
Identifier Type: -
Identifier Source: org_study_id
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