Breast Cancer, Cancer Metastatic, Gastric Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer
Conditions
Keywords
chick embryo chorioallantoic membrane, in ovo technology, cancer, Metastatic cancer, CTC, process automation
Brief summary
A variety of in vivo experimental models have been established for the studies of human cancer using both cancer cell lines and patient-derived xenografts (PDXs). In order to meet the aspiration of precision medicine, the in vivo murine models have been widely adopted. However, common constraints such as high cost, long duration of experiments, and low engraftment efficiency remained to be resolved. The chick embryo chorioallantoic membrane (CAM) is an alternative model to overcome some of these limitations. The chick CAM is shown to be a robust model for both the inoculation of cell lines and grafting of patient tumors for drug therapy evaluations and target genes/pathways analysis. The start-up INOVOTION has developed a unique, highly sensitive and reproducible CAM assay to graft human cancer cells/tumors in the chicken egg environment. INOVOTION's technology was validated for over 55 human tumor cell lines, including carcinomas, gliomas and melanomas, as well as over 30 reference drugs currently on the market. At INOVOTION, the graft of human cancer cells on the chicken CAM is currently conducted manually. To scale-up, the process was recently automated. The automation performance was assessed on cancer cells lines. The objective of this study is to demonstrate that the automation of the INOVOTION process enables tumors' proliferation using patient samples (from tumor samples or circulating tumor cells) as grafting material.
Interventions
PROCEDUREPatient sampling.
One or several bio-specimens will be sampled depending on the cohort : * Blood (40 ml) * Pleural Fluid (40 ml) * Peritoneal liquid (40 ml) * Solid tumors
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria for all cohorts \* : * Age \> 18 * Signed consent * Inclusion criteria for the Prostate cohort: * prostate adenocarcinoma histologically proven * metastatic situation * at least 2 metastatic sites * Evolutionary disease that requires a new treatment * Inclusion criteria for the Breast cohort: * HER2+ or RH+ breast adenocarcinoma histologically proven * metastatic situation * at least 2 metastatic sites * Evolutionary disease that requires a new treatment * Inclusion criteria for the Lung cohort: * Non Small Lung cancer histologically proven * metastatic situation * at least 2 metastatic sites * Evolutionary disease that requires a new treatment * Inclusion criteria for Ovarian cohort: * Ovarian cancer histologically proven * Presence of peritoneal carcinomatosis (stage IIIC or IV); with or without presence of peritoneal fluid * Inclusion criteria for Colo-Rectal cohort: * Colo-rectal cancer histologically proven * Presence of peritoneal carcinomatosis, with or without presence of peritoneal fluid * Evolutionary disease that requires a new treatment * Inclusion criteria for Gastric cohort: * Gastric cancer histologically proven * Presence of peritoneal carcinomatosis, with or without presence of peritoneal fluid *
Exclusion criteria
for all cohorts \* : * Weight \<50kg * Parallel participation in a doubled blinded study * Brain or ganglionary metastasis only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The main primary endpoint will be reached, if the xenograft rate using patients' samples is ≥ 50% with the INOVOTION automated process. | The sample outcome will be measured 19 days after egg engraftment. | A xenograft will be considered successful if proliferating human material is found in at least one of the egg engrafted with the patient sample (one patient sample being able to be used to engraft several eggs). Success = at least one successful xenograft on all engrafted eggs with a patient sample Failed: 0 successful xenograft on all engrafted eggs with a patient sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of the xenograft rate per patient sub-population and per cohort (patient blood CTC, pleural fluid, peritoneal fluid, tumor pieces) | The sample outcome will be measured 19 days after egg engraftment | A xenograft will be considered successful if proliferating human material is found in at least one of the egg engrafted with the patient sample (one patient sample being able to be used to engraft several eggs). Success = at least one successful xenograft on all engrafted eggs with a patient sample Failed: 0 successful xenograft on all engrafted eggs with a patient sample |
| Biological characteristics of the obtained xenografts (per cohort) | One to two months after egg engrafting | NGS xenograft analysis |
| Study of xenograft biological responses under different cancer drug treatment (per cohort) | 19 days after egg engraftment. | biological responses analysis. |
Countries
France
Outcome results
None listed