An observational study in Lung Adenocarcinoma and Malignant Pleural Effusions (Mpe), sponsored by Sheba Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Sheba Medical Center · Observational
This observational study evaluates if ex-vivo lung cancer drug sensitivity testing results correlate with the driver mutations found by genetic sequencing and if it can predict treatment response.
Non-small cell lung cancer (NSCLC) treatment decisions often rely on DNA sequencing, which only partially captures the tumor's mutational landscape and may miss other complex resistance mechanisms. Consequently, an unbiased functional drug screen is essential to rapidly identify optimal next-line therapies. Current drug sensitivity testing (DST) is limited by inefficient live tumor cells isolation. To address this, a rapid, unbiased DST platform utilizing FDA-approved targeted therapies was developed. Our approach uses malignant pleural effusions (MPEs) as a rich source of viable tumor cells. Because MPEs are highly heterogeneous, tumor cells are first identified via EpCAM flow cytometry, and the sample is enriched for tumor cells by depleting CD45+ immune cells using antibody-coated magnetic beads. These enriched tumor cells are then seeded into drug-containing plates. Following 72-hour incubation, cell viability is assessed using the CellTiter-Glo assay. Treatment efficacy is determined by the degree of reduction in cell viability at a range of drug concentrations, where the most effective treatment is the drug that reduces cell viability at the lowest concentration range.
To link clinical outcome and ex-vivo drug response assays, the investigators systematically measure drug sensitivity and resistance of primary tumor cells ex-vivo using a diverse compound library for individual patients in need of treatment. By systematically analyzing ex-vivo drug response patterns, tumors should be functionally grouped, by response phenotype. While for the purpose of this study selection of a specific treatment will not be based on ex-vivo drug response assays, clinical response- and follow-up data of patients will be prospectively collected in parallel.
418 studies on the registry are indexed under Adenocarcinoma of Lung; 79 are open to participants now.
This study's planned enrollment of 400 is above the median of 211 across 90 observational studies indexed under Adenocarcinoma of Lung.
Browse Adenocarcinoma of Lung studies →Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.
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Patients with pleural effusion with a diagnosis of a lung cancer or suspected to be diagnosed with lung cancer according to their CT imaging, who are in need for pleural effusion drainage due to shortness of breath, and are willing to donate effusion for ex-vivo drug sensitivity testing.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Non-Interventional Study
Non-Interventional Study, patients go through pleural drainage due to shortness of breath
Statistically significant correlation between patients' drug response by ex-vivo drug profiling and expected drug sensitivity according to genetic sequencing
Ex-vivo drug sensitivity categorizes drugs as sensitive/not sensitive. Results will be compared with the expected sensitivity of drugs according to the driver mutation found be genetic sequencing. For example, in EGFR-driven lung cancer, the tumor cells are expected to be more sensitive to EGFR-targeting drugs than to ALK-targeting drugs.
Time frame: From enrollment until results of clinical genetic sequencing and drug sensitivity testing are obtained (within 3 weeks).
Accuracy of patients' drug response prediction by ex-vivo drug profiling
Ex-vivo drug sensitivity categorizes drugs as sensitive/not sensitive. Results will be compared with clinical outcome of patient (response vs. progressive disease as defined by RECISET score)
Time frame: from date of enrollment until progression (latest 24 months)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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