RECRUITING

Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will prospectively collect airway, stool, and blood samples on 80 subjects with lung cancer undergoing immunotherapy. Investigators will evaluate airway/stool microbial signatures associated with local (lower airway) and systemic (blood) immune tone.They will then study whether microbiota and/or host signatures predict subjects' response by longitudinal assessment of the progression free survival. They will also repeat sampling after 8 weeks of immunotherapy to expand our mechanistic understanding of the response to treatment.

Official Title

Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer

Quick Facts

Study Start:2021-02-09
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04063501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  1. * Antibiotic, steroid, or chemotherapy received within the prior month since these are possible confounders that may impact the microbiome and the host immunity.
  2. * Brain metastasis (as evaluated by MRI obtained as part of standard of care staging evaluation)
  3. * FEV1\<50% predicted
  4. * Cardiovascular disease (defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure)
  5. * Renal disease
  6. * Coagulopathy
  7. * Liver disease

Contacts and Locations

Study Contact

Lira Gutierrez
CONTACT
212-263-6181
Lira.Gutierrez@nyulangone.org
Rosemary Schluger
CONTACT
Rosemary.Schluger@nyulangone.org

Principal Investigator

Leopoldo N Segal, MD, MSc
PRINCIPAL_INVESTIGATOR
New York Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Leopoldo N Segal, MD, MSc, PRINCIPAL_INVESTIGATOR, New York Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-09
Study Completion Date2026-02

Study Record Updates

Study Start Date2021-02-09
Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Cancer