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

Primary Purpose

Cancer Metastatic, Prostate Cancer, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient sampling.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer Metastatic focused on measuring chick embryo chorioallantoic membrane, in ovo technology, cancer, Metastatic cancer, CTC, process automation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • 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

Sites / Locations

  • Centre Hospitalier Lyon SudRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Centre Hospitalier Lyon Sud - Department of Medical Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

6 cohort

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Biological characteristics of the obtained xenografts (per cohort)
NGS xenograft analysis
Study of xenograft biological responses under different cancer drug treatment (per cohort)
biological responses analysis.

Full Information

First Posted
July 7, 2022
Last Updated
April 28, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05472532
Brief Title
Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)
Acronym
INOVOLINE
Official Title
Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
December 14, 2024 (Anticipated)
Study Completion Date
December 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
6 cohort
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Patient sampling.
Intervention Description
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 Outcome Measure Information:
Title
The main primary endpoint will be reached, if the xenograft rate using patients' samples is ≥ 50% with the INOVOTION automated process.
Description
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
Time Frame
The sample outcome will be measured 19 days after egg engraftment.
Secondary Outcome Measure Information:
Title
Measure of the xenograft rate per patient sub-population and per cohort (patient blood CTC, pleural fluid, peritoneal fluid, tumor pieces)
Description
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
Time Frame
The sample outcome will be measured 19 days after egg engraftment
Title
Biological characteristics of the obtained xenografts (per cohort)
Description
NGS xenograft analysis
Time Frame
One to two months after egg engrafting
Title
Study of xenograft biological responses under different cancer drug treatment (per cohort)
Description
biological responses analysis.
Time Frame
19 days after egg engraftment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis MAILLET, Dr
Phone
0478864385
Email
denis.maillet@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Léa PAYEN, Pr
Phone
04 78 86 32 08
Email
lea.payen-gay@chu-lyon.fr
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien COURAUD, PhD
Phone
0478863718
Ext
+33
Email
sebastien.couraud@chu-lyon.fr
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier GLEHEN, Pr
Phone
4 78 86 23 71
Ext
+33
Email
olivier.glehen@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Olivier GLEHEN, Pr
Facility Name
Centre Hospitalier Lyon Sud - Department of Medical Oncology
City
Pierre-Bénite
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis MAILLET, MD
Phone
0478864385
Ext
+33
Email
denis.maillet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Denis MAILLET, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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