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French National Registry of Rare Peritoneal Surface Malignancies (RENAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02834169
Recruitment Status : Unknown
Verified August 2017 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Despite advances in the management of and changes in clinical practice, little is known about the epidemiology, patterns of care and outcomes of rare peritoneal surface malignancies patients in France.

In order to better understand the characteristics of rare peritoneal surface malignancies and to evaluate treatment strategies, the RENAPE registry aims at the collection of data from patients presenting with a rare peritoneal surface malignancy in France. Data will be entered prospectively in a specifically designed and secured web database.

All RENAPE's centres and physicians are invited to register patients with a rare peritoneal surface malignancy diagnosis and to participate to the registry. Data will be evaluated within regular time frames, focusing on types of rare peritoneal surface malignancies, treatment modalities and patient outcomes (e.g. survival, recurrence), thereby contributing to the better understanding of these rare cancers.


Condition or disease Intervention/treatment
Rare Peritoneal Surface Malignancies Pseudomyxoma Peritonei Peritoneal Mesothelioma Desmoplastic Small Round Cell Tumor Psammocarcinoma Primary Peritoneal Serous Carcinoma Diffuse Peritoneal Leiomyomatosis Appendiceal Mucinous Neoplasms Other: Non interventional

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 2171 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 8 Years
Official Title: French National Registry of Rare Peritoneal Surface Malignancies (RENAPE Registry)
Study Start Date : October 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
pseudomyxoma peritonei
Data from pseudomyxoma peritonei cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
 Other: Non interventional
Data collection
peritoneal mesothelioma
Data from peritoneal mesothelioma cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
 Other: Non interventional
Data collection
desmoplastic small round cell tumor
Data from desmoplastic small round cell tumor cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
 Other: Non interventional
Data collection
psammocarcinoma
Data from primary peritoneal serous carcinoma cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
 Other: Non interventional
Data collection
primary peritoneal serous carcinoma
Data from primary peritoneal serous carcinoma cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
 Other: Non interventional
Data collection
diffuse peritoneal leiomyomatosis
Data from diffuse peritoneal leiomyomatosis cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
 Other: Non interventional
Data collection
appendiceal mucinous neoplasms
Data from appendiceal mucinous neoplasms cases will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and patient outcomes (resulting from treatment or disease).
 Other: Non interventional
Data collection


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of rare peritoneal surface malignancies [ Time Frame: year 5 ]
    Collect detailed clinical and histological diagnosis for estimating annual incidence rate


Secondary Outcome Measures :
  1. Impact of specific treatment strategies [ Time Frame: year 5 ]
    Collect detailed therapeutic strategies (surgical procedure, chemotherapy, etc.) on patients with rare peritoneal surface malignancies


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospectively or retrospectively diagnosed patients with rare peritoneal surface malignancies.
Criteria

Inclusion Criteria:

  • Patients are eligible if they have a histologically proven rare peritoneal surface malignancy.

Exclusion Criteria:

  • Histological diagnostic of peritoneal surface malignancy not confirmed
  • Expected clinical follow up data not available
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): NCT02834169


Locations
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Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: François-Noël GILLY, Prof Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet, PIERRE-BENITE, FRANCE, 69495
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02834169    
Other Study ID Numbers: 69HCL16_0406
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by Hospices Civils de Lyon:
Rare peritoneal surface malignancies
pseudomyxoma peritonei
peritoneal mesothelioma
desmoplastic small round cell tumor
psammocarcinoma
 primary peritoneal serous carcinoma
diffuse peritoneal leiomyomatosis
appendiceal mucinous neoplasms
registry
population-based database
Additional relevant MeSH terms:
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Neoplasms
Mesothelioma
Mesothelioma, Malignant
Cystadenocarcinoma, Serous
Desmoplastic Small Round Cell Tumor
Pseudomyxoma Peritonei
Peritoneal Neoplasms
Leiomyomatosis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenoma
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cystadenocarcinoma
Adenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Sarcoma
Neoplasms, Connective and Soft Tissue
Adenocarcinoma, Mucinous
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases