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NCT06615830Toborzás még nem indult

Predictive Value of Transcriptome-based OncoTreat/Oncotarget and Organoid Testing in Metastatic Pancreatic Cancer.

HIPANC-002 - Observational Performance Study of Transcriptome-Based OncoTreat/OncoTarget Testing With Patient-Derived Organoids in Metastatic Pancreatic Cancer

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 11.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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. Overall 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. Nowadays, 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. PDOs 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. Overall, 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. For 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.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Megfigyeléses
Résztvevők száma
185 (tervezett)
Első benyújtás
2024. szept. 1.
Kezdés
2026. jún. 1.
Elsődleges befejezés
2030. dec.
Fő szponzor
Prof. Dr. med. Dres. h.c. Jan Schmidt, MME
NCT-szám
NCT06615830

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 185
  • 2026. jún. 1. és az elsődleges befejezés (2030. dec.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy
  • Severe or uncontrolled concurrent illness
  • Myocardial infarction within the previous 6 months

Más betegség

  • Known allergies or intolerance to one or more compounds present in one of the first line or second line regimens
  • Heart failure (NYHA class III-IV)
  • Active viral infection from HIV, HBV or HCV, even if under antiretroviral treatment

Egyéb

  • ECOG PS >2
  • Patients who are pregnant or breastfeeding

Kiket keres a vizsgálat

  • Informed Consent as documented by signature
  • Patients older than 18 years
  • Patients with metastatic pancreatic ductal adenocarcinoma
  • At least one lesion amenable for surgical excisional biopsy
  • ECOG Performance status 0-2
  • Radiologically measurable disease
  • Life expectancy > 3 months
  • Absolute leucocyte count >1.5 G/l, platelets >100 G/l
  • Serum creatinine <1.5 times of the upper limit of normal or Clearance >50ml/min (according to the CKD-EPI formula)

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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