An observational study in Lung Cancer Stage IV, sponsored by Holy Cross Hospital, Maryland. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-24.
Sponsored by Holy Cross Hospital, Maryland · Observational
This prospective, observational study will evaluate whether vitro testing of tumor tissue and white blood cells from patients with lung cancer who are being treated with immune checkpoint inhibitors and other standard of care approaches, predicts clinical response to these agents.
Overall Goal: The long-term goal of this study is to predict whether checkpoint inhibitors will be effective in individual patients with solid tumors.
Objectives: In this pilot study to be conducted in ten subjects with lung cancer who are to receive checkpoint inhibitors, we will use cellular and molecular techniques to characterize
Planned enrollment:
Methods for Informed Consent:
Investigators will approach subjects for informed consent
Exclusion Criteria:
DNA sequencing and functional testing of peripheral blood mononuclear cells. DNA and RNA sequencing and immune cell analysis of tumor. Clinical response at 12 months.
Anti-tumor immune response
Tumor antigen presentation and anti-tumor T-cell response
Time frame: 12 months
Clinical response
Clinical response is defined as 50% or greater decrease of the sum of the products of two-dimensional measurements of lesions on imaging within the first year.
Time frame: 12 months for each subject
Tumor microenvironment
Tumor mutation burden from tumor genome landscape using DNA sequencing, tumor transcriptome with RNA sequencing, tumor infiltrating immune cells with flow cytometry
Time frame: 24 months total study duration
Plan to share: Yes — Data sharing: The data generated in this study will be available to The Holy Cross Health Institutional Review Board, Inc., Investigators named in this protocol, and Officials of the FDA and HHS. Published information following completion of the study will be provided to study patients.
Supporting information: Csr
This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.