Ex Vivo Drug Response Profiling and Outcome Prediction in Lung Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSheba Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of pleural effusion in patient 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.
Patient's written informed consent present.
Ability to understand the nature of the trial and the trial related procedures and to comply with them.
Disqualifiers
negative cytology for malignancy in the last 6 months
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-Interventional Study, patients go through pleural drainage due to shortness of breath
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Patients with diagnosis of a Lung adenocarcinoma with the need of pleural drainage due to MPE1 intervention
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov