Malignant MesotheliomaNCT03558932
IP3R Modulation by Cancer Genes in Mesothelioma
An observational study of Malignant Mesothelioma, run by KU Leuven.
Trial summary
Obtaining pleural biopsies in cases of malignant mesothelioma to detect molecular mechnisms and signal transduction Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Malignant Mesothelioma
- What is being tested?
- pleural biopsy
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jun 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: mesothelioma
Who may be able to join
- suspicion of mesothelioma
- referral for diagnostic thoracoscopy
Who cannot join
- contra-indication for thoracoscopy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: IP3R Modulation by Cancer Genes Bcl-2 & PKM2 in Mesothelioma
Obtaining pleural biopsies in cases of malignant mesothelioma to detect molecular mechnisms and signal transduction
- Conditions
- Malignant Mesothelioma
- Being tested
- pleural biopsy
- 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 biopsyDiagnostic test
diagnostic sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural biopsy
Biopsy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startJan 2019 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yserbyt Jonas, KU Leuven
- Investigators
- Jonas Yserbyt, Principal investigator, Catholic university Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558932
- Sponsor's protocol ID
- IP3mesov1
- Status last verified
- Jun 2018
- First submitted
- 23 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IP3R Modulation by Cancer Genes Bcl-2 & PKM2 in Mesothelioma
- ClinicalTrials.gov ID
- NCT03558932
- Acronym / sponsor ID
- IP3mesov1
- Conditions
- Malignant Mesothelioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 15 Jun 2018 (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.
Obtaining pleural biopsies in cases of malignant mesothelioma to detect molecular mechnisms and signal transduction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mesothelioma
Key inclusion criteria (2 listed)
- suspicion of mesothelioma
- referral for diagnostic thoracoscopy
Key exclusion criteria (1 listed)
- contra-indication for thoracoscopy
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 biopsydiagnostic sampling | Diagnostic test | – |
Primary outcome
Pleural biopsy
Time frame: 5 years
Biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- 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. This study is not recruiting at the moment.
Jonas Yserbyt principal investigator
Catholic university Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Mesothelioma, run by KU Leuven.
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 2 inclusion and 1 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 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Jonas Yserbyt (+32 16 34 68 01, jonas.yserbyt@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleural biopsy (time frame: 5 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 15 Jun 2018.