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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05193006
Other study ID # 69HCL21_1120
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 28, 2021
Est. completion date January 1, 2023

Study information

Verified date December 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date January 1, 2023
Est. primary completion date July 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - - peritoneal malignant mesothelioma Exclusion Criteria: - opposition to reuse personnal data

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Belgium UZ Gent Gent
France University Hospital of Lyon Pierre-Bénite
Germany Institut f. Pathologie und Neuropathologie Tübingen
India Zydus Hospitals Ahmedabad
Norway The Norwegian Radium Hospital Oslo
Portugal Fundação Champalimaud Lisboa

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

Belgium,  France,  Germany,  India,  Norway,  Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of pronostic impact of nuclear grade in comparison with combined grade in peritoneal malignant mesothelioma Assessment by the review of pathologists 3 months to 4 years
See also
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Recruiting NCT05001880 - Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma Phase 2
Recruiting NCT05449366 - Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma Phase 1/Phase 2