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

March 29, 2021 updated by: University Hospital, Strasbourg, France

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testing of anti-cancer drugs
Time Frame: 3 years
Obtaining organoids from healthy tissue and tumor tissue. The tests will used these organoids
3 years

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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 (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on NSCLC

Clinical Trials on Organoids

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe