Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT05193006
Collaborator
(none)
300
6
12.1
50
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma
Actual Study Start Date :
Dec 28, 2021
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
peritoneal malignant mesothelioma of grade 1

peritoneal malignant mesothelioma of grade 1

Other: No intervention
No intervention

peritoneal malignant mesothelioma of grade 2

peritoneal malignant mesothelioma of grade 2

Other: No intervention
No intervention

peritoneal malignant mesothelioma of grade 3

peritoneal malignant mesothelioma of grade 3

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. Assessment of pronostic impact of nuclear grade in comparison with combined grade in peritoneal malignant mesothelioma [3 months to 4 years]

    Assessment by the review of pathologists

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    • peritoneal malignant mesothelioma
Exclusion Criteria:
  • opposition to reuse personnal data

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Gent Gent Belgium 9000
2 University Hospital of Lyon Pierre-Bénite France 69495
3 Institut f. Pathologie und Neuropathologie Tübingen Germany 72076
4 Zydus Hospitals Ahmedabad India
5 The Norwegian Radium Hospital Oslo Norway N-0310
6 Fundação Champalimaud Lisboa Portugal 1400-038

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05193006
Other Study ID Numbers:
  • 69HCL21_1120
First Posted:
Jan 14, 2022
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022