Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos

Sponsor
University of Pisa
Study ID
NCT03668418
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Fluorouracil — DRUG
    The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
  • Lederfolin — DRUG
    The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
  • Oxaliplatin — DRUG
    The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
  • Irinotecan — DRUG
    The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
  • Docetaxel — DRUG
    The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
  • Cisplatin — DRUG
    The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
  • Epirubicin — DRUG
    The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
  • Gemcitabine — DRUG
    The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
  • Nab paclitaxel — DRUG
    The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment

Study Details

The study consists in a co-clinical trial by using zebrafish embryos. Specifically, an observational prospective clinical trial on patients operated of epato-biliar-pancreatic cancers and gastro-intestinal cancers undergoing a chemotherapy treatment will be run concurrently to an animal trial on zebrafish embryos xenotransplanted with patient cancer cells in order to demonstrate that zebrafish model is able to predict the therapeutic regimen with the best efficacy for each patient.

Key Dates

Start date
Jun 1, 2018
Status verified
Sep 2018
Primary completion
May 31, 2021
Completion
May 31, 2022

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Colorectal cancer
    Patients operated for colorectal cancer with or without liver metastasis undergoing a chemotherapy treatment after surgery
  • Arm: Esophagus/gastric cancer
    Patients operated for esophagus/gastric cancer undergoing a chemotherapy treatment after surgery
  • Arm: Biliary duct cancer
    Patients operated for biliary duct cancer undergoing a chemotherapy treatment after surgery
  • Arm: Pancreatic cancer
    Patients operated for pancreatic cancer undergoing a chemotherapy treatment after surgery

Primary Outcome Measure

Correspondence with chemo-sensitivity data collected in zebrafish model [ Time Frame: 18 months after the surgery ]

Central Contacts

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