“STUDY ON THE SELECTION OF CANCER MEDICATIONS USING CULTURED 'MINI-TUMOR COPIES' ('ORGANOIDS') AND MOLECULAR TESTING IN ADVANCED PANCREATIC CANCER“
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
• 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)
Studienstandort
Zürich
(BASEC)
Sponsor
PROF. DR. MED. JAN SCHMIDT KAPPELISTRASSE 7 8002 ZUERICH
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
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)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
31.03.2025
(BASEC)
ICTRP Studien-ID
nicht verfügbar
Offizieller Titel (Genehmigt von der Ethikkommission)
«SINGLE-CENTRE, PHASE 2, OPEN LABEL, TWO INDEPENDENT ARMS STUDY ASSESSING MOLECULAR- AND ORGANOID-DRIVEN TUMORAL CHEMOSENSITIVITY IN METASTASTITC PANCREATIC CANCER» (BASEC)
Wissenschaftlicher Titel
nicht verfügbar
Öffentlicher Titel
nicht verfügbar
Untersuchte Krankheit(en)
nicht verfügbar
Untersuchte Intervention
nicht verfügbar
Studientyp
nicht verfügbar
Studiendesign
nicht verfügbar
Ein-/Ausschlusskriterien
nicht verfügbar
nicht verfügbar
Primäre und sekundäre Endpunkte
nicht verfügbar
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
nicht verfügbar
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar