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NCT Number: NCT05472532

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

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.

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Key information

Conditions

Cancer Metastatic Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Lyon Sud, Pierre-Bénite, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Patient sampling.

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. Biological characteristics of the obtained xenografts (per cohort)

    Time frame: One to two months after egg engrafting

    NGS xenograft analysis

  3. Study of xenograft biological responses under different cancer drug treatment (per cohort)

    Time frame: 19 days after egg engraftment.

    biological responses analysis.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: INOVOLINE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2022
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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