Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture) (INOVOLINE)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Breast Cancer; Gastric Cancer; Lung Cancer; Ovarian Cancer; Prostate Cancer; Cancer Metastatic

Treatments: Procedure: Patient sampling.

Study type: Interventional

Funder types: Other

Identifiers

NCT05472532

69HCL18_0492

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

132 participants in 1 patient group

6 cohort

Experimental group

Description:

Prostate Cohorte : Castrate resistant metastatic prostate cancer patient Breast cohort : HER2+ ou RH+ metastatic breast cancer patient Lung cohort : Non-small cell lung metastatic lung cancer patient Ovarian cohort : Ovarian cancer with peritoneal carcinomatosis Colorectal cohort : Colorectal cancer with peritoneal carcinomatosis Gastric cancer : Gastric cancer with peritoneal carcinomatosis

Treatment:

Procedure: Patient sampling.