Clinical trial NCT05472532: Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)
Official title: Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Metastatic
Prostate Cancer
Breast Cancer
Lung Cancer
Ovarian Cancer
Gastric Cancer
Keywords: chick embryo chorioallantoic membrane
in ovo technology
cancer
Metastatic cancer
CTC
process automation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: The main primary endpoint will be reached, if the xenograft rate using patients' samples is ≥ 50% with the INOVOTION automated process.
timeFrame: The sample outcome will be measured 19 days after egg engraftment.
Secondary outcomes:
measure: Measure of the xenograft rate per patient sub-population and per cohort (patient blood CTC, pleural fluid, peritoneal fluid, tumor pieces)
timeFrame: The sample outcome will be measured 19 days after egg engraftment
measure: Biological characteristics of the obtained xenografts (per cohort)
timeFrame: One to two months after egg engrafting
measure: Study of xenograft biological responses under different cancer drug treatment (per cohort)
timeFrame: 19 days after egg engraftment.
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud - Department of Medical Oncology
Study officials:
References: