Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma

Peritoneal Malignant Mesothelioma Clinical Trial

Official title:

Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193006
• Other study ID #: 69HCL21_1120
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Lung Neoplasms
• Mesothelioma
• Mesothelioma, Malignant
• Peritoneal Malignant Mesothelioma

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