RECRUITING

Assess Diversity of Gut Microbiome in Met NSCLC in Correlation to Tx & Adverse Effects

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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 is a pilot study collecting data on the diversity and composition of gut microbiomes in subjects with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) while receiving treatment for NSCLC.

Official Title

A Pilot Study to Assess the Diversity of Gut Microbiome in Metastatic Non-Small Cell Lung Cancer (NSCLC) in Correlation to Treatment Effects and Adverse Effects

Quick Facts

Study Start:2024-01-31

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06221800

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 1. Advanced/Metastatic non-small cell lung cancer NSCLC patients. * 2. The patient himself/herself must be 18 years of age on day of signing informed consent. * 3. The subject has signed the informed consent form. * 4. The patient must be eligible to receive FDA approved and non-approved PD1 inhibitors (i.e. pembrolizumab, nivolumab) or PDL1 inhibitor (i.e. atezolizumab, durvalumab) either single agent or as combination therapy with chemotherapy, or be eligible to receive FDA approved and non-approved tyrosine kinase inhibitors. * 5. The subject will be registered upon submission of the samples. When submitted on separate dates, the submission occurring later will be considered the date of registration	* 1. Those subjects who are determined clinically unstable of the participation of this study as determined by the PI or treating physician will be excluded and asked to focus on their treatment.

Inclusion Criteria

Exclusion Criteria

* 1. Advanced/Metastatic non-small cell lung cancer NSCLC patients.
* 2. The patient himself/herself must be 18 years of age on day of signing informed consent.
* 3. The subject has signed the informed consent form.
* 4. The patient must be eligible to receive FDA approved and non-approved PD1 inhibitors (i.e. pembrolizumab, nivolumab) or PDL1 inhibitor (i.e. atezolizumab, durvalumab) either single agent or as combination therapy with chemotherapy, or be eligible to receive FDA approved and non-approved tyrosine kinase inhibitors.
* 5. The subject will be registered upon submission of the samples. When submitted on separate dates, the submission occurring later will be considered the date of registration

* 1. Those subjects who are determined clinically unstable of the participation of this study as determined by the PI or treating physician will be excluded and asked to focus on their treatment.

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Principal Investigator

Misako Nagasaka, MD,PhD

PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Misako Nagasaka, MD,PhD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

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 Date2024-01-31

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-01-31

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Non Small Cell Lung Cancer