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Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma

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ClinicalTrials.gov Identifier: NCT05193006
Recruitment Status : Recruiting
First Posted : January 14, 2022
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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
Peritoneal Malignant Mesothelioma Other: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma
Actual Study Start Date : December 28, 2021
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
squamous cell carcinoma of the oropharynx
Criteria

Inclusion Criteria:

  • - peritoneal malignant mesothelioma

Exclusion Criteria:

  • opposition to reuse personnal data
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05193006


Locations
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Belgium
UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Anne HOORENS, MD    +32 9 332 36 63    Anne.Hoorens@uzgent.be   
France
University Hospital of Lyon Recruiting
Pierre-Bénite, France, 69495
Contact: Nazim Benzerdkeb, MD    00 44 78 86 44 69    nazim.benzerdjeb@chu-lyon.fr   
Germany
Institut f. Pathologie und Neuropathologie Recruiting
Tübingen, Germany, 72076
Contact: Wiebke Solass Wiebke Solass, MD    07071 29-82270    Wiebke.Solass@med.uni-tuebingen.de   
India
Zydus Hospitals Recruiting
Ahmedabad, India
Contact: Loma Parikh Loma Parikh, MD    : +91 9824015858    drlomaparikh@gmail.com   
Norway
The Norwegian Radium Hospital Recruiting
Oslo, Norway, N-0310
Contact: Ben Davidson Ben Davidson, MD    47-22782415    bend@medisin.uio.no   
Portugal
Fundação Champalimaud Recruiting
Lisboa, Portugal, 1400-038
Contact: Mireia Castillo-Martin Mireia Castillo-Martin, MD    +351) 210480048    mireia.castillo@fundacaochampalimaud.pt   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT05193006    
Other Study ID Numbers: 69HCL21_1120
First Posted: January 14, 2022    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021

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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:
prognostic factors
peritoneal malignant mesothelioma
mesothelioma
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases