Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma

NCT05193006 | Unknown

• 1 other identifier: 69HCL21_1120
• Study Type: observational
• Target: 300
• Locations: 6 countries
• Sites: 6

Brief 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.

Conditions

Peritoneal Malignant Mesothelioma

Keywords

prognostic factors; peritoneal malignant mesothelioma; mesothelioma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

peritoneal malignant mesothelioma of grade 1

peritoneal malignant mesothelioma of grade 1

Other: No intervention

peritoneal malignant mesothelioma of grade 2

peritoneal malignant mesothelioma of grade 2

Other: No intervention

peritoneal malignant mesothelioma of grade 3

peritoneal malignant mesothelioma of grade 3

Other: No intervention

Interventions

No intervention OTHER

No intervention

peritoneal malignant mesothelioma of grade 1; peritoneal malignant mesothelioma of grade 2; peritoneal malignant mesothelioma of grade 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

squamous cell carcinoma of the oropharynx

You may qualify if:

• \- peritoneal malignant mesothelioma

You may not qualify if:

• opposition to reuse personnal data

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (6)

UZ Gent

Ghent, 9000, Belgium

RECRUITING

University Hospital of Lyon

Pierre-Bénite, 69495, France

RECRUITING

Institut f. Pathologie und Neuropathologie

Tübingen, 72076, Germany

RECRUITING

Zydus Hospitals

Ahmedabad, India

RECRUITING

The Norwegian Radium Hospital

Oslo, N-0310, Norway

RECRUITING

Fundação Champalimaud

Lisbon, 1400-038, Portugal

RECRUITING

MeSH Terms

Conditions

Mesothelioma

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 14, 2022
• Study Start: December 28, 2021
• Primary Completion: July 15, 2022
• Study Completion: January 1, 2023
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

BE (1); DE (1); NO (1); PT (1); FR (1); IN (1)