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

Breast Cancer Clinical Trial

— INOVOLINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472532
• Other study ID #: 69HCL18_0492
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: December 14, 2024

Study information

• Verified date: February 2023
• Source: Hospices Civils de Lyon
• Contact: Denis MAILLET, Dr
• Phone: 0478864385
• Email: denis.maillet[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 14, 2024
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Cancer Metastatic
• Gastric Cancer
• Lung Cancer
• Neoplastic Cells, Circulating
• Ovarian Cancer
• Prostate Cancer

Intervention

Procedure:
• Patient 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

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Centre Hospitalier Lyon Sud - Department of Medical Oncology	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main primary endpoint will be reached, if the xenograft rate using patients' samples is = 50% with the INOVOTION automated process.	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	The sample outcome will be measured 19 days after egg engraftment.
Secondary	Measure of the xenograft rate per patient sub-population and per cohort (patient blood CTC, pleural fluid, peritoneal fluid, tumor pieces)	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	The sample outcome will be measured 19 days after egg engraftment
Secondary	Biological characteristics of the obtained xenografts (per cohort)	NGS xenograft analysis	One to two months after egg engrafting
Secondary	Study of xenograft biological responses under different cancer drug treatment (per cohort)	biological responses analysis.	19 days after egg engraftment.