High Throughput Screening Device Based on 3D Nano-matrices and 3D Tumors With Functional Vascularization

NSCLC Clinical Trial

— TUMOVASC  

Official title:

High Throughput Screening Device Based on 3D Nano-matrices and 3D Tumors With Functional Vascularization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04826913
• Other study ID #: 8036
• Status: Not yet recruiting
• Start date: April 2021
• Est. completion date: April 2024

Study information

• Verified date: March 2021
• Source: University Hospital, Strasbourg, France
• Contact: Pierre Emmanuel FALCOZ
• Phone: +33 3 88 11 67 68
• Email: pierre-emmanuel.falcoz[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Almost 85% of new therapeutic molecules are abandoned before the clinical trial stage. Most of these failures currently concern cancer therapies.

In order to optimize the development of these molecules and allow the development of precision medicine, an innovative screening device that is as close as possible to in vivo is necessary.

For this reason, the platform the investigators are setting up takes into account tumor vascularization as well as the 3D microenvironment.

The platform the investigators intend to set up is based on 4 cornerstones:

• the formation of patient-derived organoids seems to be the best option to take into account the microenvironment and cellular interactions.

• the vascular network: the formation of a peri-tumoral vascular network, either by using HUVECS cells or by using endothelial cells from the patient.

• the extracellular matrix, and the set of proteins it contains, is a major element of in vivo interaction. Moreover, the presence of a matrix is a key element for the development of vascularization in vitro.

• Functional tumor microenvironment: peri-tumor vascularization is necessary but not sufficient to claim to recreate a tumor microenvironment. It must be functionalized, and this implies the use of a microfluidic system.

This ready-to-use platform will be used on tumor biopsies of the patient, to constitute a tool for personalized medicine. This could even be a future component of decision at multidisciplinary board meetings.

The main objective of our research is the constitution of organoids derived from the patient in order to select, via a screening device, the best anti-tumor therapy to administer to the patient.

A secondary objective is to collect lymphocytes from the patient's blood in order to test the effectiveness of therapies mediated by the immune system (immunotherapy).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient whose age is = 18 years old

• Patient with non-small cell bronchopulmonary cancer (NSCLC), at any stage, undergoing surgery in the Thoracic Surgery Department of the New Civil Hospital, Strasbourg.

• Patient who agreed to participate in this observational study.

• Patient affiliated to a social security system

Exclusion Criteria:

• Refusal to participate in the study

• Known hepatitis, known HIV

• Subject under safeguard of justice

• Subject under guardianship or trusteeship

• Inability to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject)

• Pregnant Women

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• NSCLC

Intervention

Device:
• Organoids
Use of an innovative device to improve the management of patients with NSCLC for precision medicine. The different drugs used can be conventional chemotherapy (cisplatin, carboplatin, pemetrexed), targeted therapies or immunotherapy molecules. It is also planned to use radiotherapy on our drug testing device.

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testing of anti-cancer drugs	Obtaining organoids from healthy tissue and tumor tissue. The tests will used these organoids	3 years