Mesothelioma, MalignantSCITH-MESONCT04823741
Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma
An observational study of Mesothelioma, Malignant and Gene Abnormality, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Malignant pleural mesothelioma (MPM) is a rare pleural cancer, which could be primary or secondary to an asbestos exposure. To enhance our knowledge of this rare disease, an exploration of genetic and tumor mechanism is mandatory. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Mesothelioma, Malignant, Gene Abnormality, Pleural Mesothelioma
- What is being tested?
- PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2022to 11 Feb 2026
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patient with suspected malignant pleural mesothelioma requiring surgical biopsy for diagnosis
Who may be able to join
- age >18
- suspected MPM requiring VATS biopsy after multidisciplinary oncologic board validation
- patient able to understand study objectives and able to give an informed consent
- patient affiliated to an healthcare society.
Who cannot join
- pregnancy
- mental disease, psychiatric disorder
- patient under protection regimen
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Département de chirurgie thoracique
Bron, 69677
Jean Michel MAURY, 04.72.35.75.90 ext. +33, jean-michel.maury@chu-lyon.fr
About this study
Malignant pleural mesothelioma (MPM) is a rare pleural cancer, which could be primary or secondary to an asbestos exposure. To enhance our knowledge of this rare disease, an exploration of genetic and tumor mechanism is mandatory. One of the principal difficulty is to harvest sufficient tumour pieces to perform multi-omics analysis. The goal of the SCITH-MESO study is to harvest larges pieces of tumour during a routine surgical procedure of MPM diagnosis by mean of pleural biopsies during VATS surgery. Operating samples will increase a tissue bank collection (CRB).
- Being tested
- PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA
- Keywords
- malignant pleural mesothelioma, intra tumoral heterogeneity, genetic abnormalities
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMAGenetic
All patient with suspected malignant pleural mesothelioma requiring surgical biopsy after validation in oncologic multidisciplinary board will be included. During a standardized routine procedure of pleural biopsy by mean of general anesthesia and video thoracoscopic approach, 3 - 5 biopsies are realized. During this procedure, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
| Study group | Role | What they receive |
|---|---|---|
| PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA | All patient with suspected malignant pleural mesothelioma requiring surgical biopsy after validation in oncologic multidisciplinary board will be included. During a standardized routine procedure of pleural biopsy by mean of general anesthesia and video thoracoscopic approach, 3 - 5 biopsies are realized. During this procedure, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques). Receives: Genetic: PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
For patients with MPM, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
For patients with MPM, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
Measured: day 1 (day of chirurgie)
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 start11 Feb 2022
- Primary completion11 Feb 2026 (estimated)
- Study completion11 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesothelioma, MalignantStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823741
- Sponsor's protocol ID
- 69HCL20_0997
- Other IDs
- 2021-A00748-33
- Acronym
- SCITH-MESO
- Status last verified
- Jan 2024
- First submitted
- 26 Mar 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT04823741
- Acronym / sponsor ID
- SCITH-MESO / 69HCL20_0997
- Keywords
- malignant pleural mesothelioma, intra tumoral heterogeneity, genetic abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 11 Feb 2026 (estimated)
- Study completion
- 11 Feb 2026 (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.
Malignant pleural mesothelioma (MPM) is a rare pleural cancer, which could be primary or secondary to an asbestos exposure. To enhance our knowledge of this rare disease, an exploration of genetic and tumor mechanism is mandatory. One of the principal difficulty is to harvest sufficient tumour pieces to perform multi-omics analysis. The goal of the SCITH-MESO study is to harvest larges pieces of tumour during a routine surgical procedure of MPM diagnosis by mean of pleural biopsies during VATS surgery. Operating samples will increase a tissue bank collection (CRB).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA | – | Genetic: PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMAAll patient with suspected malignant pleural mesothelioma requiring surgical biopsy after validation in oncologic multidisciplinary board will be included. During a standardized routine procedure of pleural biopsy by mean of general anesthesia and video thoracoscopic approach, 3 - 5 biopsies are realized. During this procedure, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patient with suspected malignant pleural mesothelioma requiring surgical biopsy for diagnosis
Key inclusion criteria (4 listed)
- age >18
- suspected MPM requiring VATS biopsy after multidisciplinary oncologic board validation
- patient able to understand study objectives and able to give an informed consent
- patient affiliated to an healthcare society.
Key exclusion criteria (3 listed)
- pregnancy
- mental disease, psychiatric disorder
- patient under protection regimen
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 |
|---|---|---|
| PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMAAll patient with suspected malignant pleural mesothelioma requiring surgical biopsy after validation in oncologic multidisciplinary board will be included. During a standardized routine procedure of pleural biopsy by mean of general anesthesia and video thoracoscopic approach, 3 - 5 biopsies are realized. During this procedure, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques). | Genetic | PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA |
Primary outcome
For patients with MPM, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
Time frame: day 1 (day of chirurgie)
For patients with MPM, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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 Mesothelioma, Malignant and Gene Abnormality, run by Hospices Civils de Lyon 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 3 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 Feb 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 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 Jean-Michel MAURY, MD (04.72.35.75.90 ext. +33, jean-michel.maury@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For patients with MPM, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques). (time frame: day 1 (day of chirurgie)). 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 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.