Pancreatic Cancer Clinical Trial
— xenoZOfficial title:
Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos
NCT number | NCT03668418 |
Other study ID # | 70213 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | May 31, 2022 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients operated of epato-biliar-pancreatic cancers and gastro-intestinal cancers (stage III and IV) undergoing a chemotherapy treatment Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero-Universitaria Pisana | Pisa |
Lead Sponsor | Collaborator |
---|---|
University of Pisa | Azienda Ospedaliero, Universitaria Pisana |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Response rate | Complete response (CR) — complete disappearance of clinical evidence of a tumour. Radiographically equivocal lesions must remain stable or regress. Partial response (PR) — 50% or greater decrease in the sum of products of the longest perpendicular diameters of measured lesion compared to baseline. Stable disease (SD) — no significant change in disease status. Lesion may show a <50% decrease in sum of products of longest perpendicular diameters or an increase of <25%. Progressive disease (PD) — a 25% increase in area of a lesion. Appearance of new lesions constitutes progressive disease. |
3 months after the surgery | |
Secondary | Overall survival | The length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive | 3 months after the surgery | |
Secondary | Time to tumour progression | The length of time from the date of start of treatment for the disease until the disease starts to get worse or spread to other parts of the body | 3 months after the surgery | |
Secondary | Response rate | Complete response (CR) — complete disappearance of clinical evidence of a tumour. Radiographically equivocal lesions must remain stable or regress. Partial response (PR) — 50% or greater decrease in the sum of products of the longest perpendicular diameters of measured lesion compared to baseline. Stable disease (SD) — no significant change in disease status. Lesion may show a <50% decrease in sum of products of longest perpendicular diameters or an increase of <25%. Progressive disease (PD) — a 25% increase in area of a lesion. Appearance of new lesions constitutes progressive disease. |
6 months after the surgery | |
Secondary | Overall survival | The length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive | 6 months after the surgery | |
Secondary | Time to tumour progression | The length of time from the date of start of treatment for the disease until the disease starts to get worse or spread to other parts of the body | 6 months after the surgery | |
Secondary | Response rate | Complete response (CR) — complete disappearance of clinical evidence of a tumour. Radiographically equivocal lesions must remain stable or regress. Partial response (PR) — 50% or greater decrease in the sum of products of the longest perpendicular diameters of measured lesion compared to baseline. Stable disease (SD) — no significant change in disease status. Lesion may show a <50% decrease in sum of products of longest perpendicular diameters or an increase of <25%. Progressive disease (PD) — a 25% increase in area of a lesion. Appearance of new lesions constitutes progressive disease. |
12 months after the surgery | |
Secondary | Overall survival | The length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive | 12 months after the surgery | |
Secondary | Time to tumour progression | The length of time from the date of start of treatment for the disease until the disease starts to get worse or spread to other parts of the body | 12 months after the surgery | |
Secondary | Response rate | Complete response (CR) — complete disappearance of clinical evidence of a tumour. Radiographically equivocal lesions must remain stable or regress. Partial response (PR) — 50% or greater decrease in the sum of products of the longest perpendicular diameters of measured lesion compared to baseline. Stable disease (SD) — no significant change in disease status. Lesion may show a <50% decrease in sum of products of longest perpendicular diameters or an increase of <25%. Progressive disease (PD) — a 25% increase in area of a lesion. Appearance of new lesions constitutes progressive disease. |
18 months after the surgery | |
Secondary | Overall survival | The length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive | 18 months after the surgery | |
Secondary | Time to tumour progression | The length of time from the date of start of treatment for the disease until the disease starts to get worse or spread to other parts of the body | 18 months after the surgery |
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