Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos
xenoZ
1 other identifier
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedSeptember 12, 2018
September 1, 2018
3 years
June 19, 2018
September 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Correspondence with chemo-sensitivity data collected in zebrafish model
Comparative evaluation between prospectively collected data on clinical outcome and chemo-sensitivity data collected in zebrafish model
18 months after the surgery
Secondary Outcomes (12)
Response rate
3 months after the surgery
Overall survival
3 months after the surgery
Time to tumour progression
3 months after the surgery
Response rate
6 months after the surgery
Overall survival
6 months after the surgery
- +7 more secondary outcomes
Study Arms (4)
Colorectal cancer
Patients operated for colorectal cancer with or without liver metastasis undergoing a chemotherapy treatment after surgery
Esophagus/gastric cancer
Patients operated for esophagus/gastric cancer undergoing a chemotherapy treatment after surgery
Biliary duct cancer
Patients operated for biliary duct cancer undergoing a chemotherapy treatment after surgery
Pancreatic cancer
Patients operated for pancreatic cancer undergoing a chemotherapy treatment after surgery
Interventions
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Eligibility Criteria
Oncological patients from Azienda Ospedaliero-Universitaria Pisana
You may qualify if:
- \- patients operated of epato-biliar-pancreatic cancers and gastro-intestinal cancers (stage III and IV) undergoing a chemotherapy treatment
You may not qualify if:
- age below 18 years
- significant co-morbid cardiovascular and respiratory disease
- early stage of disease, (iv) history of prior cancer or prior treatment with any chemotherapy regimen
- pregnant and lactating females
- patients requiring urgent/ emergency interventions
- life expectancy \< 12 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pisalead
- Azienda Ospedaliero, Universitaria Pisanacollaborator
Study Sites (1)
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56124, Italy
Related Publications (2)
Usai A, Di Franco G, Piccardi M, Cateni P, Pollina LE, Vivaldi C, Vasile E, Funel N, Palmeri M, Dente L, Falcone A, Giunchi D, Massolo A, Raffa V, Morelli L. Zebrafish Patient-Derived Xenografts Identify Chemo-Response in Pancreatic Ductal Adenocarcinoma Patients. Cancers (Basel). 2021 Aug 17;13(16):4131. doi: 10.3390/cancers13164131.
PMID: 34439284DERIVEDUsai A, Di Franco G, Colucci P, Pollina LE, Vasile E, Funel N, Palmeri M, Dente L, Falcone A, Morelli L, Raffa V. A Model of a Zebrafish Avatar for Co-Clinical Trials. Cancers (Basel). 2020 Mar 13;12(3):677. doi: 10.3390/cancers12030677.
PMID: 32183229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Morelli, Prof
University of Pisa
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2018
First Posted
September 12, 2018
Study Start
June 1, 2018
Primary Completion
May 31, 2021
Study Completion
May 31, 2022
Last Updated
September 12, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share