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

April 28, 2023 updated by: Hospices Civils de Lyon

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
        • Principal Investigator:
          • Olivier GLEHEN, Pr
      • Pierre-Bénite, France
        • Not yet recruiting
        • Centre Hospitalier Lyon Sud - Department of Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6 cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The sample outcome will be measured 19 days after egg engraftment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
NGS xenograft analysis
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.
biological responses analysis.
19 days after egg engraftment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Anticipated)

December 14, 2024

Study Completion (Anticipated)

December 14, 2024

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (Actual)

July 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0492

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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