[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563412":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":10,"responsibleParty":27,"collaborators":31,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":10,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":10,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":66,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":10},{"fullName":5,"class":6},"Klinik Hirslanden, Zurich","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Predictive value of Oncotreat\u002FOncotarget testing in palliative chemotherapy in pancreatic cancer",null,"The study will include patients with diagnosis of metastatic pancreatic adenocarcinoma. After complete disease staging, patients will undergo laparoscopic surgical biopsy of metastatic tumoral tissue. The tissue will serve for the generation of Oncotreat and Oncotarget tests as well as for patient-derived organoids on which potentially predicted drugs will be benchmarked.\n\nEach patient will receive the standard first-line and second-line chemotherapy (chosen among Gemcitabine-Abraxane, or Abraxane-Gemcitabine-FOLFOX or FOLFIRINOX, based on the clinical judgement of the treating oncologist).\n\nWhen progression occurs predictive value of the test with regard to Progression-free Survival (PFS) will be analyzed.",[13],{"name":14,"affiliation":15,"role":16},"Jan Schmidt, Prof. Dr. med. Dres. h.c., MME","Swiss Surgery\u002FHirslanden Zurich","STUDY_DIRECTOR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":10,"email":22},"Jan Schmidt, Prof. Dr. med. Dres. h.c. MME","CONTACT","+ 41 442092505","jan.schmidt@hirslanden.ch",{"name":24,"role":20,"phone":25,"phoneExt":10,"email":26},"Alexander Siebenhüner, PD, MD","0041-44-387-3780","alexander.siebenhuener@hirslanden.ch",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Prof. Dr. med. Dres. h.c. Jan Schmidt, MME","Prof. Dr. med. Dres. h.c. MME",[32,33,35],{"name":5,"class":6},{"name":34,"class":6},"Insel Gruppe AG, University Hospital Bern",{"name":36,"class":37},"Columbia Research Laboratories","INDUSTRY","100563412","predictive-value-of-transcriptome-based-oncotreatoncotarget-and-organoid-testing-in-metastatic-pancreatic-cancer-100563412",false,"NCT06615830","Predictive Value of Transcriptome-based OncoTreat\u002FOncotarget and Organoid Testing in Metastatic Pancreatic Cancer.","HIPANC-002 - Observational Performance Study of Transcriptome-Based OncoTreat\u002FOncoTarget Testing With Patient-Derived Organoids in Metastatic Pancreatic Cancer","Inclusion criteria:\n\n* Informed Consent as documented by signature\n* Patients older than 18 years\n* Patients with metastatic pancreatic ductal adenocarcinoma\n* At least one lesion amenable for surgical excisional biopsy\n* ECOG Performance status 0-2\n* Radiologically measurable disease\n* Life expectancy \\> 3 months\n* Absolute leucocyte count \\>1.5 G\u002Fl, platelets \\>100 G\u002Fl\n* Serum creatinine \\\u003C1.5 times of the upper limit of normal or Clearance \\>50ml\u002Fmin (according to the CKD-EPI formula)\n\nExclusion criteria:\n\n* Known allergies or intolerance to one or more compounds present in one of the first line or second line regimens\n* Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy\n* ECOG PS \\>2\n* Heart failure (NYHA class III-IV)\n* Severe or uncontrolled concurrent illness\n* Active viral infection from HIV, HBV or HCV, even if under antiretroviral treatment\n* Myocardial infarction within the previous 6 months\n* Patients who are pregnant or breastfeeding","ALL","18 Years",{"count":48,"type":49},185,"ESTIMATED","OBSERVATIONAL","Pancreatic cancer is burdened by a survival of barely 10% at 5 years. About 80% of new cases do not qualify for surgery due to either locally-advanced or metastatic disease. In patients with good performance status (PS), palliative first-line treatments mainly consist of combination regimens, such as FOLFIRINOX, modified FOLFIRINOX or Gemcitabine-Abraxane. For subjects with a poor PS, instead, guidelines recommend single-agent infusions (e.g. Gemcitabine, Capecitabine or 5-FU alone). Nevertheless, upon disease progression therapeutic options are still scarce and with limited sustained efficacy.\n\nOverall survival in metastatic pancreatic cancer ranges between 9.1 and 13.5 months, while progression-free survival under either FOLFIRINOX or Gemcitabine-Abraxane spans between 5.5 and 6.4 months. This timespan reduces even further when standard second-line regimens must be initiated upon disease progression.\n\nNowadays, genomic and transcriptomic analysis are crucial tools in cancer research that enable the identification of genetic mutations and alterations that drive the development and progression of cancer. By studying the changes in the DNA and RNA sequences of cancer cells, researchers can gain insights into the underlying molecular mechanisms of cancer and identify potential therapeutic targets. Genomic analysis can identify specific mutations or alterations that are present in cancer cells, while transcriptomic analysis can reveal changes in gene expression that may be linked to disease progression or response to treatment. These analyses are an essential component for the development of precision medicine approaches, which aim to tailor cancer treatment to the individual genetic profile of each patient.\n\nPDOs can replicate in vitro the biological, genetic and molecular aspects of the primary tumour. Some of their advantages include their rapid growth compared to xenografts, the possibility to perform high-throughput drug screening, and their direct application to precision oncology by predicting best therapies. In this study they will be used as an in vitro comparator of the molecular tests to the clinical course of the patient.\n\nOverall, combining genomic and transcriptomic analysis with PDO technology in cancer research might lead to exponential capacity to provide oncologic patients with extremely tailored and effective cancer treatments in the future.\n\nFor HIPANC-002 these tests are being evaluated as non-interventional investigational IVD's. Test results are not to be used for protocol mandated therapy decisions.",[53,54,55,56],"Pancreas Neoplasms","Pancreatic Neoplasms","Pancreatic Cancer Metastatic","Pancreatic Adenocarcinoma Metastatic",[58,59,60,61,62,63,64,65],"Pancreatic cancer","Pancreatic adenocarcinoma","Metastatic pancreatic adenocarcinoma","Organoid","Organoid-driven chemotherapy","Darwin Oncotreat","Darwin Oncotarget","Personalized chemotherapy","NOT_YET_RECRUITING","2026-02-07",{"date":69,"type":70},"2026-02-11","ACTUAL",{"date":72,"type":49},"2026-06-01",{"date":74,"type":49},"2031-01",{"name":29,"class":6}]