Lung CancerNCT03979170
Patient-derived Organoids of Lung Cancer to Test Drug Response
An observational study of Lung Cancer and Organoid, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 3 years. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) Model of lung cancer to predict the clinical efficacy of anti-cancer drugs, in order to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Organoid
- What is being tested?
- Lung tumor resection
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2019to 30 Dec 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients (estimated 50 patients) with histologically proven lung cancer undergoing surgery related to this cancer at the University Hospitals of Geneva.
Who may be able to join
- Histologically proven lung cancer
- Age ≥ 18
- Written informed and signed consent
- Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour
Who cannot join
- Less than 18 years of age
- Not able to give informed consent (language, intellectual capacities, etc.)
- Not accessible to biopsy and/or surgery sample
- Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, 1205
Veronique SERRE-BEINIER, PhD, 223795107 ext. 41, veronique.serre-beinier@hcuge.ch
Frederic TRIPONEZ, MD
About this study
This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 3 years. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) Model of lung cancer to predict the clinical efficacy of anti-cancer drugs, in order to predict the best chemotherapy regimen for each given patient.
Read the detailed description
The aim of the project is to use a combination of patient-derived organoid models:
- To amplify tumour tissue to obtain enough material for genomic and histological analysis
- to characterize the lung cancer sub-type
- To predict treatment (non)response.
The following points will be addressed:
- First, the investigators plan to establish and characterize formation of organoids from biopsies of patients with lung cancer: in spheroids, in the 3D cellular model OncoCilAirTM (OncoTheis), and on the chick chorioallantoic membrane (CAM). Patient-derived organoids from tumoural tissue (PDO) will be characterized and compared to the original tumour.
- Second, the investigators will test the chemoresponse (chemosensitivity and chemoresistance) of organoids to anti-cancer treatment.
- Conditions
- Lung Cancer, Organoid
- Being tested
- Lung tumor resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung tumor resectionProcedure or surgery
lung tumor resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-derived organoid establishment
Successful generation of lung cancer organoids (growth of lung tumoral cells). The rate of successful generation of lung cancer organoids could vary with the age of the patient, the histological and molecular subtype of lung cancer
Measured: 3 years
Patient-derived organoid validation
Proportion of patient-derived organoids that are histologically and genetically identical to the source tumour
Measured: 5 years
Secondary outcomes (2)
Drug sensitivity
Drug sensitivity of patient-derived tumour organoids (drug screening and chemotherapy resistance test) Secondary drug effects on patient-derived normal lung organoids
Measured: 2019 - 2023
Prediction of the response to treatment by the patient-derived organoids
The drug sensitivity was tested on patient-derived tumour organoids, which is compared with clinical response of the chemo- or targeted therapy treatment.
Measured: 2020 - 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Apr 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederic TRIPONEZ, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979170
- Sponsor's protocol ID
- 2018-02395
- Other IDs
- 2018
- Status last verified
- May 2024
- First submitted
- 15 Apr 2019
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mueggler A, Pilotto E, Perriraz-Mayer N, Jiang S, Addeo A, Bedat B, Karenovics W, Triponez F, Serre-Beinier V. An Optimized Method to Culture Human Primary Lung Tumor Cell Spheroids. Cancers (Basel). 2023 Nov 25;15(23):5576. doi: 10.3390/cancers15235576.
PubMed 38067281
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-derived Organoids of Lung Cancer to Test Drug Response
- ClinicalTrials.gov ID
- NCT03979170
- Acronym / sponsor ID
- 2018-02395
- Conditions
- Lung Cancer, Organoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 7 Jun 2019 (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.
This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 3 years. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) Model of lung cancer to predict the clinical efficacy of anti-cancer drugs, in order to predict the best chemotherapy regimen for each given patient.
Detailed description
The aim of the project is to use a combination of patient-derived organoid models:
- To amplify tumour tissue to obtain enough material for genomic and histological analysis
- to characterize the lung cancer sub-type
- To predict treatment (non)response.
The following points will be addressed:
- First, the investigators plan to establish and characterize formation of organoids from biopsies of patients with lung cancer: in spheroids, in the 3D cellular model OncoCilAirTM (OncoTheis), and on the chick chorioallantoic membrane (CAM). Patient-derived organoids from tumoural tissue (PDO) will be characterized and compared to the original tumour.
- Second, the investigators will test the chemoresponse (chemosensitivity and chemoresistance) of organoids to anti-cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients (estimated 50 patients) with histologically proven lung cancer undergoing surgery related to this cancer at the University Hospitals of Geneva.
Key inclusion criteria (4 listed)
- Histologically proven lung cancer
- Age ≥ 18
- Written informed and signed consent
- Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour
Key exclusion criteria (4 listed)
- Less than 18 years of age
- Not able to give informed consent (language, intellectual capacities, etc.)
- Not accessible to biopsy and/or surgery sample
- Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.
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 |
|---|---|---|
| Lung tumor resectionlung tumor resection | Procedure or surgery | – |
Primary outcome
Patient-derived organoid establishment
Time frame: 3 years
Successful generation of lung cancer organoids (growth of lung tumoral cells). The rate of successful generation of lung cancer organoids could vary with the age of the patient, the histological and molecular subtype of lung cancer
Patient-derived organoid validation
Time frame: 5 years
Proportion of patient-derived organoids that are histologically and genetically identical to the source tumour
2 secondary outcomes
Drug sensitivity
Time frame: 2019 - 2023
Prediction of the response to treatment by the patient-derived organoids
Time frame: 2020 - 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Background: PubMed 38067281Mueggler A, Pilotto E, Perriraz-Mayer N, Jiang S, Addeo A, Bedat B, Karenovics W, Triponez F, Serre-Beinier V. An Optimized Method to Culture Human Primary Lung Tumor Cell Spheroids. Cancers (Basel). 2023 Nov 25;15(23):5576. doi: 10.3390/cancers15235576.
- Individual participant dataSharing planned: No
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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.
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 Lung Cancer and Organoid, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 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: looking for participants now, as of the sponsor's last update on 3 Jun 2024. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronique SERRE-BEINIER, PhD ((0)223795107 ext. +41, veronique.serre-beinier@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-derived organoid establishment (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979170, which also lists 1 linked publication.
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 3 Jun 2024.