Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)
INOVOLINE
1 other identifier
interventional
101
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2025
CompletedNovember 20, 2025
November 1, 2025
2 years
July 7, 2022
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Biological characteristics of the obtained xenografts (per cohort)
One to two months after egg engrafting
Study of xenograft biological responses under different cancer drug treatment (per cohort)
19 days after egg engraftment.
Study Arms (1)
6 cohort
EXPERIMENTALProstate 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Age \> 18
- Signed consent
- prostate adenocarcinoma histologically proven
- metastatic situation
- at least 2 metastatic sites
- Evolutionary disease that requires a new treatment
- HER2+ or RH+ breast adenocarcinoma histologically proven
- metastatic situation
- at least 2 metastatic sites
- Evolutionary disease that requires a new treatment
- Non Small Lung cancer histologically proven
- metastatic situation
- at least 2 metastatic sites
- Evolutionary disease that requires a new treatment
- Ovarian cancer histologically proven
- +6 more criteria
You may not qualify if:
- Weight \<50kg
- Parallel participation in a doubled blinded study
- Brain or ganglionary metastasis only
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Lyon Sud - Department of Medical Oncology
Pierre-Bénite, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 25, 2022
Study Start
February 14, 2023
Primary Completion
February 14, 2025
Study Completion
February 14, 2025
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share