“STUDY ON THE SELECTION OF CANCER MEDICATIONS USING CULTURED 'MINI-TUMOR COPIES' ('ORGANOIDS') AND MOLECULAR TESTING IN ADVANCED PANCREATIC CANCER“
Résumé de l'étude
In this study, we investigate how meaningful the testing of additional drug groups on small tumor copies ('organoids') is, and whether this method is effective and safe for determining the better or worse efficacy of study medications. Additionally, the tumor cells will be tested for their molecular characteristics, which may provide insights into their sensitivity or resistance to drug groups in individual cases.
(BASEC)
Intervention étudiée
At the beginning of the study, a laparoscopy will be performed to obtain some tumor tissue ('Biopsy No. 1'). The laparoscopy is done under general anesthesia. A biopsy would also be necessary if the patient does not participate in the study. From this tissue, small tumor copies are cultured in the laboratory, known as 'organoids'. Furthermore, the tumor tissue will be examined for its molecular properties using specialized tests. If any of these control examinations show disease progression (a so-called 'progress'), the treatment will be switched to another chemotherapy. This new therapy will be selected based on the insights gained from the molecular examinations of the tumor tissue taken during the biopsy and the behavior of the small tumor copies against the tested medications. Before the start of this new chemotherapy phase, another laparoscopy will be performed under general anesthesia, and new biopsies of the tumor will be taken ('Biopsy No. 2'). Small tumor copies will again be cultured from these already 'treated' tumor cells, and they will be molecularly examined once more to gain further insights into tumor behavior and to select additional therapy options.
(BASEC)
Maladie en cours d'investigation
METASTATIC PANCREATIC CANCER
(BASEC)
• Signed patient information including completed patient information • Patients older than 18 years • Patients with metastatic pancreatic cancer • At least one tumor lesion accessible for surgical biopsy • ECOG status 0-2 • Radiologically measurable disease • Life expectancy > 3 months • Leukocyte count >1.5 G/l, platelet count >100 G/l • Serum creatinine <1.5 x upper normal range or clearance >50ml/min (CKD-EPI formula) (BASEC)
Critères d'exclusion
• Known allergies or intolerances to the medications used for first-line chemotherapy • Necessity for total anticoagulation that cannot be interrupted for a biopsy • ECOG PS >2 • Heart failure (NYHA class III-IV) • Severe uncontrolled comorbidity • Active viral infection (HIV, HBV, or HCV, even under antiviral therapy) • Myocardial infarction within the last 6 months • Pregnant or breastfeeding patients (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
PROF. DR. MED. JAN SCHMIDT KAPPELISTRASSE 7 8002 ZUERICH
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Dres. h.c. Jan Schmidt, MME Senior Visceral Surgeon SWISS SURGERY Hirslanden Clinics, Zürich (CH) Kappelistrasse 7, 8002 Zürich
+41 44 209 25 05
jan.schmidt@clutterhirslanden.chSWISS SURGERY HIRSLANDEN KLINIKEN ZÜRICH
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
31.03.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
«SINGLE-CENTRE, PHASE 2, OPEN LABEL, TWO INDEPENDENT ARMS STUDY ASSESSING MOLECULAR- AND ORGANOID-DRIVEN TUMORAL CHEMOSENSITIVITY IN METASTASTITC PANCREATIC CANCER» (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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