NSCLCTUMOVASCNCT04826913
High Throughput Screening Device Based on 3D Nano-matrices and 3D Tumors With Functional Vascularization
An observational study of NSCLC, run by University Hospital, Strasbourg, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Organoids
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2021to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Pierre Emmanuel FALCOZ, +33 3 88 11 67 68, pierre-emmanuel.falcoz@chru-strasbourg.fr
Joseph SEITLINGER, +33 3 83 85 85 85, joseph.seitlinger@chru-strasbourg.fr
About this study
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.
Read more
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).
- Conditions
- NSCLC
- Being tested
- Organoids
- Keywords
- organoids, drug testing, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrganoidsDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing of anti-cancer drugs
Obtaining organoids from healthy tissue and tumor tissue. The tests will used these organoids
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826913
- Sponsor's protocol ID
- 8036
- Acronym
- TUMOVASC
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Throughput Screening Device Based on 3D Nano-matrices and 3D Tumors With Functional Vascularization
- ClinicalTrials.gov ID
- NCT04826913
- Acronym / sponsor ID
- TUMOVASC / 8036
- Conditions
- NSCLC
- Keywords
- organoids, drug testing, immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrganoidsUse 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. | Device | – |
Primary outcome
Testing of anti-cancer drugs
Time frame: 3 years
Obtaining organoids from healthy tissue and tumor tissue. The tests will used these organoids
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Emmanuel FALCOZ (+33 3 88 11 67 68, pierre-emmanuel.falcoz@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing of anti-cancer drugs (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.