Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryo… (NCT05472532) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)
France101 participantsStarted 2023-02-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.