Peritoneal Malignant MesotheliomaNCT05193006
Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma
An observational study of Peritoneal Malignant Mesothelioma, run by Hospices Civils de Lyon at 6 sites in 6 countries.
Trial summary
Malignant peritoneal mesothelioma is a rare neoplasm. The most common type, the epithelioid type, has been further divided into histological patterns of tubulo-papillary, acinar, adenomatoid, micropapillary, or solid. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritoneal Malignant Mesothelioma
- How many people
- 300 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 28 Dec 2021to 1 Jan 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: squamous cell carcinoma of the oropharynx
Who may be able to join
- - peritoneal malignant mesothelioma
Who cannot join
- opposition to reuse personnal data
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent
Ghent, 9000
Anne HOORENS, MD, +32 9 332 36 63, Anne.Hoorens@uzgent.be
France1 site, 1 recruiting
- Recruiting
University Hospital of Lyon
Pierre-Bénite, 69495
Nazim Benzerdkeb, MD, 00 44 78 86 44 69, nazim.benzerdjeb@chu-lyon.fr
Germany1 site, 1 recruiting
- Recruiting
Institut f. Pathologie und Neuropathologie
Tübingen, 72076
Wiebke Solass Wiebke Solass, MD, 07071 29-82270, Wiebke.Solass@med.uni-tuebingen.de
India1 site, 1 recruiting
- Recruiting
Zydus Hospitals
Ahmedabad
Loma Parikh Loma Parikh, MD, : +91 9824015858, drlomaparikh@gmail.com
Norway1 site, 1 recruiting
- Recruiting
The Norwegian Radium Hospital
Oslo, N-0310
Ben Davidson Ben Davidson, MD, 47-22782415, bend@medisin.uio.no
Portugal1 site, 1 recruiting
- Recruiting
Fundação Champalimaud
Lisbon, 1400-038
Mireia Castillo-Martin Mireia Castillo-Martin, MD, +351) 210480048, mireia.castillo@fundacaochampalimaud.pt
About this study
Malignant peritoneal mesothelioma is a rare neoplasm. The most common type, the epithelioid type, has been further divided into histological patterns of tubulo-papillary, acinar, adenomatoid, micropapillary, or solid. Its prognosis is improved by the use of a locoregional treatment combining extensive cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), which increases survival up to 50 months. Histology is one of the most important prognostic variable that, forms the basis for treatment decisions. However, the prognostic of the epithelioid type varies greatly due to its tumor heterogeneity. It is therefore necessary to find prognostic factors of malignant epithelioid peritoneal mesothelioma in order to better define the therapeutic strategy. Among histological factors, solid growth, tumor necrosis, nuclear atypia, and mitotic count were found to be independent prognostic factors in epithelioid malignant pleural mesothelioma. However, in epithelioid malignant peritoneal mesothelioma (EMPM), these factors were studied in small and heterogeneous series in terms of histological growth and definitions used for histological factors. The present large study was conducted to investigate the prognostic impact of several histologic factors in EMPM. Their prognosis impacts were assessed using overall survival (OS) and progression-free survival (PFS) in EMPM.
- Conditions
- Peritoneal Malignant Mesothelioma
- Being tested
- No intervention
- Keywords
- prognostic factors, peritoneal malignant mesothelioma, mesothelioma
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| peritoneal malignant mesothelioma of grade 1 | peritoneal malignant mesothelioma of grade 1 Receives: Other: No intervention | |
| peritoneal malignant mesothelioma of grade 2 | peritoneal malignant mesothelioma of grade 2 Receives: Other: No intervention | |
| peritoneal malignant mesothelioma of grade 3 | peritoneal malignant mesothelioma of grade 3 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pronostic impact of nuclear grade in comparison with combined grade in peritoneal malignant mesothelioma
Assessment by the review of pathologists
Measured: 3 months to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start28 Dec 2021
- Primary completion15 Jul 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Malignant MesotheliomaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 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
- NCT05193006
- Sponsor's protocol ID
- 69HCL21_1120
- Status last verified
- Dec 2021
- First submitted
- 31 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT05193006
- Acronym / sponsor ID
- 69HCL21_1120
- Conditions
- Peritoneal Malignant Mesothelioma
- Keywords
- prognostic factors, peritoneal malignant mesothelioma, mesothelioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 14 Jan 2022 (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 peritoneal mesothelioma is a rare neoplasm. The most common type, the epithelioid type, has been further divided into histological patterns of tubulo-papillary, acinar, adenomatoid, micropapillary, or solid. Its prognosis is improved by the use of a locoregional treatment combining extensive cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), which increases survival up to 50 months. Histology is one of the most important prognostic variable that, forms the basis for treatment decisions. However, the prognostic of the epithelioid type varies greatly due to its tumor heterogeneity. It is therefore necessary to find prognostic factors of malignant epithelioid peritoneal mesothelioma in order to better define the therapeutic strategy. Among histological factors, solid growth, tumor necrosis, nuclear atypia, and mitotic count were found to be independent prognostic factors in epithelioid malignant pleural mesothelioma. However, in epithelioid malignant peritoneal mesothelioma (EMPM), these factors were studied in small and heterogeneous series in terms of histological growth and definitions used for histological factors. The present large study was conducted to investigate the prognostic impact of several histologic factors in EMPM. Their prognosis impacts were assessed using overall survival (OS) and progression-free survival (PFS) in EMPM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| peritoneal malignant mesothelioma of grade 1 | – | Other: No interventionperitoneal malignant mesothelioma of grade 1 |
| peritoneal malignant mesothelioma of grade 2 | – | Other: No interventionperitoneal malignant mesothelioma of grade 2 |
| peritoneal malignant mesothelioma of grade 3 | – | Other: No interventionperitoneal malignant mesothelioma of grade 3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- squamous cell carcinoma of the oropharynx
Key inclusion criteria (1 listed)
- - peritoneal malignant mesothelioma
Key exclusion criteria (1 listed)
- opposition to reuse personnal data
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 |
|---|---|---|
| No interventionNo intervention | Other | peritoneal malignant mesothelioma of grade 1, peritoneal malignant mesothelioma of grade 2, peritoneal malignant mesothelioma of grade 3 |
Primary outcome
Assessment of pronostic impact of nuclear grade in comparison with combined grade in peritoneal malignant mesothelioma
Time frame: 3 months to 4 years
Assessment by the review of pathologists
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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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.
Institut f. Pathologie und Neuropathologie
Tübingen, Germany
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Malignant Mesothelioma, run by Hospices Civils de Lyon at 6 sites in 6 countries.
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 1 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, France, Germany, India, Norway and 1 more country. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pronostic impact of nuclear grade in comparison with combined grade in peritoneal malignant mesothelioma (time frame: 3 months to 4 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 14 Jan 2022.