Cancer MetastaticINOVOLINENCT05472532
Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)
A study testing Patient sampling. in people with Cancer Metastatic and Prostate Cancer, run by Hospices Civils de Lyon at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Metastatic, Prostate Cancer, Breast Cancer
- What is being tested?
- Patient sampling.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Feb 2023to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Signed consent
- prostate adenocarcinoma histologically proven
- metastatic situation
- at least 2 metastatic sites
- Evolutionary disease that requires a new treatment
Show all 21Show fewer
- 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
- Presence of peritoneal carcinomatosis (stage IIIC or IV); with or without presence of peritoneal fluid
- Colo-rectal cancer histologically proven
- Presence of peritoneal carcinomatosis, with or without presence of peritoneal fluid
- Evolutionary disease that requires a new treatment
- Gastric cancer histologically proven
- Presence of peritoneal carcinomatosis, with or without presence of peritoneal fluid
Who cannot join
- Weight <50kg
- Parallel participation in a doubled blinded study
- Brain or ganglionary metastasis only
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Lyon Sud - Department of Medical Oncology
Pierre-Bénite
About this study
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.
- Conditions
- Cancer Metastatic, Prostate Cancer, Breast Cancer, Lung Cancer, Ovarian Cancer, Gastric Cancer
- Being tested
- Patient sampling.
- Keywords
- chick embryo chorioallantoic membrane, in ovo technology, cancer, Metastatic cancer, CTC, process automation
- Medical subject headings
- Neoplasm Metastasis, Prostatic Neoplasms, Breast Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient sampling.Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 6 cohort | Experimental | 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 Receives: Procedure: Patient sampling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: The sample outcome will be measured 19 days after egg engraftment
Biological characteristics of the obtained xenografts (per cohort)
NGS xenograft analysis
Measured: One to two months after egg engrafting
Study of xenograft biological responses under different cancer drug treatment (per cohort)
biological responses analysis.
Measured: 19 days after egg engraftment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start14 Feb 2023
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472532
- Sponsor's protocol ID
- 69HCL18_0492
- Acronym
- INOVOLINE
- Status last verified
- Nov 2025
- First submitted
- 7 Jul 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)
- ClinicalTrials.gov ID
- NCT05472532
- Acronym / sponsor ID
- INOVOLINE / 69HCL18_0492
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6 cohort | Experimental | Procedure: Patient sampling.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | 6 cohort |
Primary outcome
The main primary endpoint will be reached, if the xenograft rate using patients' samples is ≥ 50% with the INOVOTION automated process.
Time frame: The sample outcome will be measured 19 days after egg engraftment.
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
3 secondary outcomes
Measure of the xenograft rate per patient sub-population and per cohort (patient blood CTC, pleural fluid, peritoneal fluid, tumor pieces)
Time frame: The sample outcome will be measured 19 days after egg engraftment
Biological characteristics of the obtained xenografts (per cohort)
Time frame: One to two months after egg engrafting
Study of xenograft biological responses under different cancer drug treatment (per cohort)
Time frame: 19 days after egg engraftment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient sampling. in people with Cancer Metastatic and Prostate Cancer, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main primary endpoint will be reached, if the xenograft rate using patients' samples is ≥ 50% with the INOVOTION automated process. (time frame: The sample outcome will be measured 19 days after egg engraftment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.