- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07636252
Ex Vivo Drug Response Profiling and Outcome Prediction in Lung Adenocarcinoma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Israel
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Ramat Gan, Israel, Israël, 5262100
- Recrutement
- Sheba medical center
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Contact:
- Michael Peled, MD PhD
- Numéro de téléphone: 972-3-5308420
- E-mail: michael.peled@sheba.health.gov.il
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- negative cytology for malignancy in the last 6 months
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Patients with diagnosis of a Lung adenocarcinoma with the need of pleural drainage due to MPE
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Non-Interventional Study, patients go through pleural drainage due to shortness of breath
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Statistically significant correlation between patients' drug response by ex-vivo drug profiling and expected drug sensitivity according to genetic sequencing
Délai: From enrollment until results of clinical genetic sequencing and drug sensitivity testing are obtained (within 3 weeks).
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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.
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From enrollment until results of clinical genetic sequencing and drug sensitivity testing are obtained (within 3 weeks).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Accuracy of patients' drug response prediction by ex-vivo drug profiling
Délai: from date of enrollment until progression (latest 24 months)
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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)
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from date of enrollment until progression (latest 24 months)
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Tumeurs par type histologique
- Maladies pulmonaires
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Tumeurs pleurales
- Carcinome
- Maladies pleurales
- Épanchement pleural
- Adénocarcinome du poumon
- Tumeurs pulmonaires
- Épanchement pleural malin
- Trouble myéloprolifératif chronique avec éosinophilie
Autres numéros d'identification d'étude
- SHEBA-18-5494-MP-CTIL
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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